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

Catalog Number 04641655190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2015

Event Type  malfunction  

Manufacturer Narrative

A specific root cause could not be identified as the sample was not available for further testing.Additional information for further investigation such as which result was believed to be correct was requested but was not provided.Review of the provided calibration and qc data did not indicate a general reagent or system issue.

Event Description

The customer received questionable total psa total (free + complexed) psa - prostate-specific antigen (total psa) and free psa results for an unknown number of patient samples.Of the data provided, only the data for one patient was discrepant and did not agree with the clinical status of the patient.Refer to the medwatch with patient identifier (b)(6) for the free psa assay.The initial results for the patient from cobas e411 serial number (b)(4) were total psa: 94.42 ng/ml and free psa: 15.25 ng/ml.The urologist questioned these results and sent the sample to be tested at three other sites.Site 1 (modular e170) on (b)(6) 2015: total psa: 90.19 ng/ml free psa: 22.69 ng/ml.Site 2 (cobas e411) on (b)(6) 2015: total psa: 73.99 ng/ml free psa: 13 ng/ml.Site 3 (cobas e411) on (b)(6) 2015: total psa: 67.67 ng/ml free psa: 13.77 ng/ml.The patient was not adversely affected.Review of the provided calibration data did not indicate a general reagent or system issue.

Manufacturer Narrative

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

• 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 Key: 4549115
• MDR Text Key: 13146903
• Report Number: 1823260-2015-01575
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: P990056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2015

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 Date: 07/31/2015
• Device Catalogue Number: 04641655190
• Device Lot Number: 17804501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 02/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2015
• 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 Number: 1
• Patient Age: 087 YR