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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS FREE PSA; TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA Back to Search Results
Catalog Number ASKU
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2018
Event Type  malfunction  
Manufacturer Narrative
The event occurred in: (b)(6).
 
Event Description
The customer complained of questionable elecsys free psa immunoassay (freepsa) and elecsys total psa immunoassay (tpsa) results for 1 patient tested on a cobas e 411 immunoassay analyzer.The customer tested two separate samples (sample a and sample b) from the same patient.This medwatch will cover freepsa.Please refer to the medwatch with patient identifier (b)(6) for information on the tpsa.For sample a: the initial tpsa result was 0.154 ng/ml with a repeat result of 0.163 ng/ml the initial freepsa result was 4.91 ng/ml with a repeat result of 4.89 ng/ml.For sample b: on (b)(6) 2018 the initial tpsa result was 0.207 ng/ml.The same patient sample was tested on a cobas 8000 and a tpsa result of 0.158 ng/ml was obtained.On (b)(6) 2018 the initial freepsa result was 5.05 ng/ml.The same patient sample was tested on a cobas 8000 and a freepsa result of 4.43 ng/ml was obtained.The erroneous results were not reported outside of the laboratory.There was no allegation of an adverse event.The cobas e411 serial number was (b)(4).The investigation is currently ongoing.
 
Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.
 
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Brand Name
FREE PSA
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 Key8178447
MDR Text Key131014281
Report Number1823260-2018-04981
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 03/07/2019
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 Catalogue NumberASKU
Device Lot Number293436
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/06/2018
Initial Date FDA Received12/19/2018
Supplement Dates Manufacturer Received12/06/2018
Supplement Dates FDA Received03/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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