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 07/09/2015

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.Refer to the medwatch with patient identifier (b)(6) for the total psa assay.The initial total psa result from the cobas 8000 analyzer was 0.750 ng/ml.The repeat result from a cobas 6000 analyzer was 0.753 ng/ml.The initial free psa result from cobas e411 serial number (b)(4) was 3.43 ng/ml.The repeat result was 3.44 ng/ml.The total psa result of 0.750 ng/ml and free psa result of 3.43 ng/ml were reported outside the laboratory.The patient was not adversely affected.As the sample was no longer available for investigation, a specific root cause could not be determined.A general reagent issue was not suspected.

Manufacturer Narrative

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

• 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: 4943003
• MDR Text Key: 6037745
• Report Number: 1823260-2015-03864
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P000027
• 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
• Report Date: 07/27/2015

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 Catalogue Number: 03289788160
• Device Lot Number: 178872
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 07/27/2015
• 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