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Adverse Event Report

BECKMAN COULTER, INC. ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER   back to search results
Model Number ACCESS 2 IMMUNOSSAY SYSTEM
Event Date 05/19/2003
Event Type  Other   Patient Outcome  Other;
Event Description

An erroneously elevated accu tnl results of 4. 53 ng/ml was generated by an access 2 instrument. The erroneously elevated result was not reported out of the lab. The customer rerun the sample for accu tni on a different chemistry analyzer and obtained a result of 0. 0 ng/ml was reported out of 0. 0 ng/ml. The sample was rerun on the access 2 instrument and 0. 0 ng/ml result was obtained. The result of 0. 0 ng/ml was reported out of the lab. There has been no change to patient treatment that can be attributed to this event.

 
Manufacturer Narrative

Service summary post-event: service conducted a performance test and the instrument initially failed. Service performed a major pm on the instrument after the performance test failed. Service repeated the performance test and the instrument passed within specifications after the pm was completed. A malfunction will be assumed for the purpose of this report. The root cause of the event is unknown and unknownable.

 
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Brand NameACCESS 2 IMMUNOASSAY SYSTEM
Type of DeviceDISCRETE PHOTOMETRIC CHEMISTRY ANALYZER
Baseline Brand NameACCESS 2 IMMUNOASSAY SYSTEM
Baseline Generic NameDISCRETE PHOTOMETRIC CHEMISTRY ANALYZER
Baseline Catalogue Number81600N
Baseline Model NumberACCESS 2 IMMUNOSSAY SYSTEM
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BECKMAN COULTER, INC.
1000 lake hazeltine drive
chaska MN 55318
Manufacturer (Section D)
BECKMAN COULTER, INC.
1000 lake hazeltine drive
chaska MN 55318
Manufacturer Contact
anne saber, director
11800 sw 147th avenue
mail stop: 32-c206
miami , FL 33116-9015
(305) 380 -2618
Device Event Key456974
MDR Report Key468048
Event Key443585
Report Number2122870-2003-00054
Device Sequence Number1
Product CodeJJE
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation UNKNOWN
Remedial Action Replace,Inspection
Type of Report Initial
Report Date 05/19/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device MODEL NumberACCESS 2 IMMUNOSSAY SYSTEM
Device Catalogue Number81600N
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/01/2002
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Database last updated on January 30, 2009

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