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 04485220190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous results for 2 patients tested for total (free + complexed) psa - prostate-specific antigen (tpsa) - total psa and free psa (free psa).It is not known if erroneous result were reported outside of the laboratory.It is not known which results are believed to be correct.This information has been requested.This medwatch will cover total psa.(b)(4).Patient 1 total psa result was 0.002 ng/dl.The free psa result was 0.015 ng/dl.Patient 2 total psa result was 0.002 ng/dl.The free psa result was 0.015 ng/dl.No adverse event occurred.The e411 analyzer serial number was (b)(4).

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

• 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 rd; indianapolis IN 46250 0457
• 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: 5619612
• MDR Text Key: 44026116
• Report Number: 1823260-2016-00553
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P990056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

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 Catalogue Number: 04485220190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2016
• 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