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

Catalog Number 04491734190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained about erroneous results for 1 patient tested for free psa (free psa) and total (free + complexed) psa - prostate-specific antigen (tpsa) (total psa).The erroneous results were reported outside of the laboratory.This medwatch will cover total psa.Refer to medwatch with patient identifier (b)(6) for information on the free psa erroneous results.The initial total psa result was 0.137 ng/ml.The initial free psa result was 2.32 ng/ml.These results were reported outside of the laboratory where the doctor questioned them.The sample was repeated and the total psa result was 0.134 ng/ml.The repeat free psa result was 2.33 ng/ml.The sample was repeated again on (b)(6) 2015 and the total psa result was 0.141 ng/ml and the free psa result was 2.34 ng/ml.A new sample was obtained on (b)(6) 2015 and the initial total psa result was 0.131 ng/ml.The initial free psa result was 2.12 ng/ml.This sample was sent to another laboratory where a siemens instrument was used.The total psa result from the siemens instrument was 1.68 ng/ml.The free psa result from the siemens instrument was 0.04 ng/ml.These results were believed to be correct and more compatible with the patient condition.No adverse event occurred.The modular analytics e module serial number was (b)(4).Calibration and quality controls were acceptable.It was noted that the patient takes finasteride to treat baldness.

Manufacturer Narrative

A patient sample was submitted for investigation.The customer's roche results were reproduced during the investigation.Based on the available information, there is an indication of an interference (the presence of auto-antibodies or an anti-idiotype antibody) in the sample causing the discrepant results.This interference is addressed in product labeling.Additionally, a strong decrease in total psa results for patients taking finasteride is well described in the labeling for that product.

• Brand Name: 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) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5151156
• MDR Text Key: 28306381
• Report Number: 1823260-2015-04340
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P990056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 02/17/2016

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 Date: 01/31/2016
• Device Catalogue Number: 04491734190
• Device Lot Number: 181675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 041 YR