MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FREE PSA; TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA

Catalog Number 03289788160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2015

Event Type  malfunction  

Event Description

The customer received questionable total psa total (free + complexed) psa - prostate-specific antigen (total psa) and free psa results for one patient sample from the analytical e module serial number (b)(4).Refer to the medwatch with patient identifier (b)(6) for the total psa assay.The initial total psa result was 0.047 ng/ml and was reported outside the laboratory as <0.1 ng/ml.The free psa result was 2.28 ng/ml and was reported outside the laboratory.These results were questioned by the physician as the total psa result was higher than the free psa result.Neither result was believed to be correct.The patient was not adversely affected.The field service representatives could not find a cause and could not replicate the issue.Assay performance checks and calibrations were performed.The customer ran qc and precision testing.All mechanical and fluidic checks passed guidelines.All qc was within limits and precision testing passed guidelines.

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.(b)(4).

Manufacturer Narrative

A specific root cause could not be identified.Based on the provided calibration and qc data, a general issue with the reagent was not indicated.

• Brand Name: FREE PSA
• Type of Device: TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA
• 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: 4576151
• MDR Text Key: 5557153
• Report Number: 1823260-2015-01809
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2015

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: 10/31/2015
• Device Catalogue Number: 03289788160
• Device Lot Number: 18024301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 03/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2015
• 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