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Adverse Event Report

BECKMAN COULTER, INC. ICON 25 HCG QUALITATIVE HCG TEST   back to search results
Catalog Number 43025
Event Date 08/12/2003
Event Type  Other   Patient Outcome  Other;
Event Description

A customer called beckman coulter regarding several discrepant urine test results. Urine samples from several pts tested negative with the icon 25 test kit. Most of the urine samples tested with the icon 25 were not the first morning void. According to the customer the same pts were tested for hcg quantitatively with serum and the results were positive. No serum quantitative results were provided. There has been no change to pt treatment that can be attributed to this event.

 
Manufacturer Narrative

The preferred urine sample to be used with the icon 25 test kit is the first morning void. No pt samples were available for additional investigation at beckman coulter. No customer devices were returned to beckman coulter. Positive and negative urine controls performed correctly on retain devices when tested at beckman coulter. Since the customer could not provide a sample to confirm or refute the false negative results, a malfunction will be assumed for this report. The root cause of event is unk and unknowable.

 
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Brand NameICON 25 HCG
Type of DeviceQUALITATIVE HCG TEST
Baseline Brand NameICON 25 HCG
Baseline Generic NameQUALITATIVE BHCG TEST
Baseline Catalogue Number43025
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BECKMAN COULTER, INC.
1050 page mill rd
palo alto CA 94304
Manufacturer (Section D)
BECKMAN COULTER, INC.
1050 page mill rd
palo alto CA 94304
Manufacturer Contact
anne saber, director
11800 sw 147th ave
mail stop: 32-c206
miami , FL 33116-9015
(305) 380 -2618
Device Event Key474133
MDR Report Key485246
Event Key460010
Report Number2916283-2003-00008
Device Sequence Number1
Product CodeJHI
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation NO INFORMATION
Remedial Action Other
Type of Report Initial
Report Date 09/09/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/09/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device Catalogue Number43025
Device LOT NumberHCG021222
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Unknown
Was the Report Sent to FDA? No
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/01/2002
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Database last updated on February 28, 2009

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