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 11/11/2011

Event Type  malfunction  

Event Description

The customer alleged they received questionable total prostate-specific antigen (tpsa) and free prostate-specific antigen (fpsa) results for one patient on their e-module.The customer stated this had been going one since 2011.The patient provided data for two samples with discrepant results.The tpsa result was 3.46 ng/ml and the fpsa result was 5.54 ng/ml.The sample was then tested on a tandem method.The tpsa result was 7.42 ng/ml and fpsa result was 2.86 ng/ml.The patient had another sample tested.The date of this test was requested but not provided.The tpsa result was 3.180 ng/ml and fpsa result was 4.74 ng/ml.Information on whether the discrepant results were reported outside the laboratory was requested but not provided.The patient was not adversely affected by this event.The tpsa and fpsa reagent lot numbers and expiration dates were requested but not provided.

Manufacturer Narrative

This event occurred in (b)(6).The specific part number involved in this event was requested but not provided.

Manufacturer Narrative

This is the same patient as was previously reported in medwatches 1823260-2013-03521-00 and 1823260-2013-07606-00.This patient is known to have the presence of an interfering substance, such as an anti-idiotype or auto-antibody.This interference is covered in the product labeling.Other reagent(s) involved in the complaint: brand name: ft3 - elecsys free psa ii.Common device name: test, prostate specific antigen,free, (noncomplexed) to distinguish prostate cancer from benign conditions.Manufacturer information: same as for total psa, total (free + complexed) psa - prostate-specific antigen (tpsa).Catalog number: 03289788190, lot number: asku, expiration date: asku.Manufacturing site: same as for total psa, total (free + complexed) psa - prostate-specific antigen (tpsa).Pma/510(k)#: p000027.

• 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 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: 3869978
• MDR Text Key: 4459266
• Report Number: 1823260-2014-04304
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04641655190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 06/04/2014
• 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