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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA); TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROS

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ROCHE DIAGNOSTICS TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA); TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROS Back to Search Results
Catalog Number 04491734160
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/07/2015
Event Type  malfunction  
Event Description
The customer received questionable total psa total (free + complexed) psa - prostate-specific antigen (total psa) and free psa results for one patient sample from the analytical e module serial number (b)(4).Refer to the medwatch with patient identifier (b)(6) for the free psa assay.The initial total psa result was 0.047 ng/ml and was reported outside the laboratory as <0.1 ng/ml.The free psa result was 2.28 ng/ml and was reported outside the laboratory.These results were questioned by the physician as the total psa result was higher than the free psa result.Neither result was believed to be correct.The patient was not adversely affected.The field service representatives could not find a cause and could not replicate the issue.Assay performance checks and calibrations were performed.The customer ran qc and precision testing.All mechanical and fluidic checks passed guidelines.All qc was within limits and precision testing passed guidelines.
 
Manufacturer Narrative
A specific root cause could not be identified.Based on the provided calibration and qc data, a general issue with the reagent was not indicated.
 
Manufacturer Narrative
It was unknown if the initial reporter sent report to the fda.(b)(4).
 
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Brand Name
TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)
Type of Device
TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROS
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 6830 5
GM   68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key4576179
MDR Text Key5557586
Report Number1823260-2015-01808
Device Sequence Number1
Product Code MTF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P990056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 03/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2015
Device Catalogue Number04491734160
Device Lot Number17692801
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Event Location Laboratory
Initial Date Manufacturer Received 02/19/2015
Initial Date FDA Received03/06/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/17/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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