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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FREE PSA IMMUNOASSAY; TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA

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ROCHE DIAGNOSTICS ELECSYS FREE PSA IMMUNOASSAY; TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA Back to Search Results
Catalog Number 07027320190
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/15/2019
Event Type  malfunction  
Manufacturer Narrative
The event occurred in (b)(6).
 
Event Description
The initial reporter complained of questionable elecsys free psa immunoassay results from an investigation sites cobas 8000 e 801 module compared to the clei psa tandem method.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The cobas e801 serial number from the investigation is (b)(4).The investigation is currently ongoing.
 
Manufacturer Narrative
The control measurement was within range the date of the event.The sample was no longer available for investigation.The measured fpsa or tpsa value of a patient¿s sample can vary depending on the testing procedure used.Therefore, fpsa or tpsa values determined on patient samples by differing testing procedures cannot be directly compared with one another.This is described in the product labeling.The investigation did not identify a product problem.The cause of the event could not be determined.
 
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Brand Name
ELECSYS FREE PSA IMMUNOASSAY
Type of Device
TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key8393893
MDR Text Key137939222
Report Number1823260-2019-00884
Device Sequence Number1
Product Code MTG
Combination Product (y/n)N
PMA/PMN Number
P000027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2019
Device Catalogue Number07027320190
Device Lot Number330860
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/15/2019
Initial Date FDA Received03/06/2019
Supplement Dates Manufacturer Received02/15/2019
Supplement Dates FDA Received03/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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