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 Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2014

Event Type  malfunction  

Event Description

The customer received questionable total psa total (free + complexed) psa - prostate-specific antigen (total psa) results for one patient from a cobas e411 analyzer and an analytical e module analyzer.On (b)(^) 2014, the result from the cobas e411 analyzer for the first sample from the patient was 0.95 ng/ml and was reported out of the laboratory.The patient came back to the laboratory because he did not believe the result as he has carcinoma of the prostate and had not yet started treatment.On (b)(6) 2014 a second sample was drawn from the patient.The result from the cobas e411 analyzer was 1.19 ng/ml.The sample was sent to other laboratory to confirm and was tested on an abbott architect analyzer.The result was 33 ng/ml.The application specialist reviewed the instrument and retested the sample in an aliquot cup.The result from the cobas e411 analyzer was 1.14 ng/ml.On (b)(6) 2014, the sample was processed in other laboratory on an analytical e module analyzer and the result was 1.01 ng/ml.The sample was processed in a fourth laboratory on a siemens instrument and the result was 33.4 ng/ml.The results from the second sample were not reported outside the laboratory.The patient was not adversely affected.

Manufacturer Narrative

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

Manufacturer Narrative

Samples from the patient were submitted for further investigation and the customer's results were verified.No interferent could be identified.A specific root cause could not be determined.

• 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: 4163872
• MDR Text Key: 4870453
• Report Number: 1823260-2014-07789
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/11/2014

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: 07/30/2015
• Device Catalogue Number: 04641655190
• Device Lot Number: 178045
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 10/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2014
• 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
• Patient Age: 070 YR