[U.S. Food and Drug Administration]
[Detailed Information]
Products with Date-Related Problems
Roche Diagnostics (Boehringer Mannheim Corp.)
FDA Classification Name(s) or
Generic Description
Trade/Brand Name(s) Model Number(s)
Advantage, III, Plus, Simplicity
NA
NA
Hospital Data Manager
NA
NA
NA
NA
736-30
736-50
737
747-100
747-200
911
912
914
917 Disk
917 Rack
NA
All
1010
2010 Disk and Rack
NA
ELB
PDM Pro
NA
NA

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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Glucose test system
Trade or Brand NameAccu-Chek
Model Number(s)Advantage, III, Plus, Simplicity
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)All
Software Version Number(s)All
Date Related ProblemUnit only has date fields for month and day, not year. Therefore, it does not recognize any year as a leap year. The date will automatically roll over from February 28 to March 1. However, February 29 can be manually entered as a valid date.
User Action NecessaryUsers are asked to refer to their owner's manual for instructions on adjusting the date in a leap year.
Solution Minor Problem - no upgrade.
Solution Date
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseFeb-04-2000
Date Last UpdatedFeb-04-2000
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Glucose test system
Trade or Brand NameAccuData GTS w/Accu-Chek III
Model Number(s)NA
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)4.26
Date Related ProblemThe Accu-Chek III only has data fields for month and day, not year. Therefore, it does not recognize an year as a leap year. The date will automatically roll over from February 28, to March 1. February 29 can be manually entered as a valid date. Versions prior to 4.26 may require an upgrade.
User Action NecessaryFor version 4.26, users are asked to refer to their owner's manual for instructions on adjusting the date in a leap year. For earlier versions, contact manufacturer for details. Version number is displayed on the opening screen for version 4.26.
Solution Minor Problem - no upgrade.
Solution Date
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseFeb-04-2000
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Glucose test system
Trade or Brand NameAccuData GTS w/Advantage
Model Number(s)NA
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)All
Date Related ProblemAll testing should be completed prior to midnight and resumed after midnight, December 31, 1999. Furthermore, Advantage only has data fields for month and day, not year. Therefore, it does not recognize any year as a leap year. The date will automatically roll over from February 28, to March 1. February 29 can be manually entered as a valid date.
User Action NecessaryUsers are asked to refer to their owner's manual for instructions on adjusting the date in a leap year.
Solution Minor Problem - no upgrade.
Solution Date
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseFeb-04-2000
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Calculator/data processing module for clinical use
Trade or Brand NameAccuData HDM
Model Number(s)Hospital Data Manager
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)2.1, 2.2, 2.2A, 3.0
Date Related ProblemWrong dates are reflected on the reports.
User Action NecessaryUpgrade to Version 2.3 (DOS) or 3.2 (Windows).
Solution Software upgrade will be provided at no cost.
Solution Date05/30/1999
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseApr-26-1999
Date Last UpdatedOct-11-1999
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Glucose test system
Trade or Brand NameAccuSoft Advantage
Model Number(s)NA
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)All
Software Version Number(s)All
Date Related ProblemUnit only has date fields for month and day, not year. Therefore, it does not recognize any year as a leap year. The date will automatically roll over from February 28 to March 1. However, February 29 can be manually entered as a valid date.
User Action NecessaryUsers are asked to refer to their owner's manual for instructions on adjusting the date in a leap year.
Solution Minor Problem - no upgrade.
Solution Date
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseJan-29-2000
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Glucose test system
Trade or Brand NameAccutrend
Model Number(s)NA
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)All
Software Version Number(s)All
Date Related ProblemUnit only has date fields for month and day, not year. Therefore, it does not recognize any year as a leap year. The date will automatically roll over from February 28 to March 1. However, February 29 can be manually entered as a valid date.
User Action NecessaryUsers are asked to refer to their owner's manual for instructions on adjusting the date in a leap year.
Solution Minor Problem - no upgrade.
Solution Date
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseJan-29-2000
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Glucose test system
Trade or Brand NameAccutrend Sensor
Model Number(s)NA
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)All
Software Version Number(s)All
Date Related ProblemUnit only has date fields for month and day, not year. Therefore, it does not recognize any year as a leap year. The date will automatically roll over from February 28 to March 1. However, February 29 can be manually entered as a valid date.
User Action NecessaryUsers are asked to refer to their owner's manual for instructions on adjusting the date in a leap year.
Solution Minor Problem - no upgrade.
Solution Date
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseJan-29-2000
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Glucose test system
Trade or Brand NameAdvantage
Model Number(s)NA
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)All
Software Version Number(s)All
Date Related ProblemUnit only has date fields for month and day, not year. Therefore, it does not recognize any year as a leap year. The date will automatically roll over from February 28 to March 1. However, February 29 can be manually entered as a valid date.
User Action NecessaryUsers are asked to refer to their owner's manual for instructions on adjusting the date in a leap year.
Solution Minor Problem - no upgrade.
Solution Date
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseJan-29-2000
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Discrete photometric chemistry analyzer for clinical use.
Trade or Brand NameBM/Hitachi
Model Number(s)736-30
Original ManufacturerHitachi Instruments Inc.
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)All
Date Related ProblemManufacturer states the device is obsolete and has no plan to assess the identified device.
User Action Necessary
Solution Product Obsolete - no upgrade.
Solution DateNA
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseApr-26-1999
Date Last UpdatedOct-18-1999
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Discrete photometric chemistry analyzer for clinical use.
Trade or Brand NameBM/Hitachi
Model Number(s)736-50
Original ManufacturerHitachi Instruments Inc.
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)All
Date Related ProblemManufacturer states the device is obsolete and has no plan to assess the identified device.
User Action Necessary
Solution Product Obsolete - no upgrade.
Solution DateNA
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseApr-26-1999
Date Last UpdatedOct-18-1999
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Discrete photometric chemistry analyzer for clinical use.
Trade or Brand NameBM/Hitachi
Model Number(s)737
Original ManufacturerHitachi Instruments Inc.
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)All
Date Related ProblemManufacturer states the device is obsolete and has no plan to assess the identified device.
User Action Necessary
Solution Product Obsolete - no upgrade.
Solution DateNA
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseApr-26-1999
Date Last UpdatedOct-18-1999
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Discrete photometric chemistry analyzer for clinical use.
Trade or Brand NameBM/Hitachi
Model Number(s)747-100
Original ManufacturerHitachi Instruments Inc.
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)Versions Prior to 05-14 / A-11
Date Related ProblemAfter December 31, 1999 the wrong date will be printed on all reports. Versions 05-14/A-11 and higher are Y2K compliant.
User Action NecessaryContact manufacturer to obtain upgrade.
Solution Software upgrade will be provided at no cost.
Solution Date05/20/1999
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseApr-26-1999
Date Last UpdatedOct-18-1999
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Discrete photometric chemistry analyzer for clinical use.
Trade or Brand NameBM/Hitachi
Model Number(s)747-200
Original ManufacturerHitachi Instruments Inc.
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)Versions prior to 05-13/A-12
Date Related ProblemAfter December 31, 1999 the wrong date will be printed on all reports. Versions 05-13/A-12 and higher are Y2K compliant.
User Action NecessaryContact manufacturer to obtain upgrade.
Solution Software upgrade will be provided at no cost.
Solution Date05/20/1999
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseApr-26-1999
Date Last UpdatedOct-18-1999
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Discrete photometric chemistry analyzer for clinical use.
Trade or Brand NameBM/Hitachi
Model Number(s)911
Original ManufacturerHitachi Instruments Inc.
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)Versions prior to 04-32
Date Related ProblemAfter December 31, 1999 the wrong dates will be printed on all reports. Versions 04-32 and higher are Y2K compliant.
User Action NecessaryContact manufacturer to obtain upgrade.
Solution Software upgrade will be provided at no cost.
Solution Date06/01/1999
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseApr-26-1999
Date Last UpdatedOct-18-1999
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Discrete photometric chemistry analyzer for clinical use.
Trade or Brand NameBM/Hitachi
Model Number(s)912
Original ManufacturerHitachi Instruments Inc.
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)Versions prior to 02-05
Date Related ProblemAfter December 31, 1999 the wrong date will be printed on all reports. Versions 02-05 and higher are Y2K compliant.
User Action NecessaryContact manufacturer to obtain upgrade.
Solution Software upgrade will be provided at no cost.
Solution Date05/20/1999
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseApr-26-1999
Date Last UpdatedOct-18-1999
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Discrete photometric chemistry analyzer for clinical use.
Trade or Brand NameBM/Hitachi
Model Number(s)914
Original ManufacturerHitachi Instruments Inc.
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)All
Date Related ProblemAfter December 31, 1999 the wrong date will be printed on all reports.
User Action NecessaryContact manufacturer to obtain upgrade.
Solution Software upgrade will be provided at no cost.
Solution Date06/15/1999
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseApr-26-1999
Date Last UpdatedOct-18-1999
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Discrete photometric chemistry analyzer for clinical use.
Trade or Brand NameBM/Hitachi
Model Number(s)917 Disk
Original ManufacturerHitachi Instruments Inc.
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)Versions prior to 02-41
Date Related ProblemAfter December 31, 1999 the wrong date will be printed on all reports. Versions 02-41 and higher are Y2K compliant.
User Action NecessaryContact manufacturer to obtain upgrade.
Solution Software upgrade will be provided at no cost.
Solution Date02/15/1999
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseApr-26-1999
Date Last UpdatedOct-18-1999
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Discrete photometric chemistry analyzer for clinical use.
Trade or Brand NameBM/Hitachi
Model Number(s)917 Rack
Original ManufacturerHitachi Instruments Inc.
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)Versions prior to 02-05
Date Related ProblemAfter December 31, 1999 the wrong date will be printed on all reports. Versions 02-05 and higher are Y2K compliant.
User Action NecessaryContact manufacturer to obtain upgrade.
Solution Software upgrade will be provided at no cost.
Solution Date02/15/1999
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseApr-26-1999
Date Last UpdatedOct-18-1999
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Calculator/data processing module for clinical use
Trade or Brand NameCamit EL
Model Number(s)NA
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)All
Software Version Number(s)All
Date Related ProblemUnit only has date fields for month and day, not year. Therefore, it does not recognize any year as a leap year. The date will automatically roll over from February 28 to March 1. However, February 29 can be manually entered as a valid date.
User Action NecessaryUsers are asked to refer to their owner's manual for instructions on adjusting the date in a leap year.
Solution Minor Problem - no upgrade.
Solution Date
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseJan-29-2000
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Data transfer device
Trade or Brand NameConNEXTion, JT-1000
Model Number(s)All
Original ManufacturerNA
FDA Regulated No
Serial Number(s)All
Software Version Number(s)All
Date Related ProblemThe devices are obsolete and no longer supported by the manufacturer. They will not be assessed for Y2K compliance.
User Action NecessaryContact your local sales representative for transition options.
Solution Product Obsolete - no upgrade.
Solution Date
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseJan-05-2000
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Discrete photometric chemistry analyzer for clinical use.
Trade or Brand NameElecSys
Model Number(s)1010
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)Versions prior to 2.0
Date Related ProblemWrong dates are reflected on the reports. Version upgrade is distributed.
User Action Necessary
Solution Software upgrade will be provided at no cost.
Solution Date02/15/1999
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseApr-26-1999
Date Last UpdatedOct-08-1999
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Discrete photometric chemistry analyzer for clinical use.
Trade or Brand NameElecSys
Model Number(s)2010 Disk and Rack
Original ManufacturerHitachi Instruments
FDA Regulated Yes
Serial Number(s)NA
Software Version Number(s)Versions prior to 02-14
Date Related ProblemThe incorrect date is printed in reports only. Version upgrade is distributed.
User Action Necessary
Solution Software upgrade will be provided at no cost.
Solution Date02/15/1999
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseApr-26-1999
Date Last UpdatedOct-07-1999
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Glucose test system
Trade or Brand NameGlucotrend Premium
Model Number(s)NA
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)All
Software Version Number(s)All
Date Related ProblemUnit only has date fields for month and day, not year. Therefore, it does not recognize any year as a leap year. The date will automatically roll over from February 28 to March 1. However, February 29 can be manually entered as a valid date.
User Action NecessaryUsers are asked to refer to their owner's manual for instructions on adjusting the date in a leap year.
Solution Minor Problem - no upgrade.
Solution Date
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseJan-29-2000
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Calculator/data processing module for clinical use
Trade or Brand NameMerlin Electronic Log
Model Number(s)ELB
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)All
Software Version Number(s)All
Date Related ProblemUnit only has date fields for month and day, not year. Therefore, it does not recognize any year as a leap year. The date will automatically roll over from February 28 to March 1. However, February 29 can be manually entered as a valid date.
User Action NecessaryUsers are asked to refer to their owner's manual for instructions on adjusting the date in a leap year.
Solution Minor Problem - no upgrade.
Solution Date
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseFeb-04-2000
Date Last UpdatedFeb-04-2000
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Calculator/data processing module for clinical use
Trade or Brand NamePDM Pro
Model Number(s)PDM Pro
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)Unspecified
Software Version Number(s)All
Date Related ProblemNo year 200 assessment is planned.
User Action Necessary
Solution Product Obsolete - no upgrade.
Solution DateNA
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseSep-25-1998
Date Last UpdatedOct-08-1999
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Glucose test system
Trade or Brand NameReflolux S
Model Number(s)NA
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)All
Software Version Number(s)All
Date Related ProblemUnit only has date fields for month and day, not year. Therefore, it does not recognize any year as a leap year. The date will automatically roll over from February 28 to March 1. However, February 29 can be manually entered as a valid date.
User Action NecessaryUsers are asked to refer to their owner's manual for instructions on adjusting the date in a leap year.
Solution Minor Problem - no upgrade.
Solution Date
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseJan-29-2000
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Federal Y2K Biomedical Equipment Clearinghouse Detail
Product with a Date-Related Problem
Manufacturer Roche Diagnostics (Boehringer Mannheim Corp.)
View products that are Y2K compliant from this manufacturer.
Division
FDA Classification Name or Generic Description Glucose test system
Trade or Brand NameReflolux SF
Model Number(s)NA
Original ManufacturerNA
FDA Regulated Yes
Serial Number(s)All
Software Version Number(s)All
Date Related ProblemUnit only has date fields for month and day, not year. Therefore, it does not recognize any year as a leap year. The date will automatically roll over from February 28 to March 1. However, February 29 can be manually entered as a valid date.
User Action NecessaryUsers are asked to refer to their owner's manual for instructions on adjusting the date in a leap year.
Solution Minor Problem - no upgrade.
Solution Date
Y2K Contact NameAnn Gerritsen
Y2K Contact Address9115 Hague Road
P.O. Box 50457
Y2K Contact City, State/Province Postal CodeIndianapolis, IN 46250-0457
Y2K Contact CountryUSA
Y2K Contact Telephone317-576-7567/800-428-5074
Y2K Contact FAX
Y2K Contact E-Mail
Date Added To DatabaseJan-29-2000
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