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 ASKU

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2015

Event Type  malfunction  

Event Description

The customer received questionable free psa and total psa total (free + complexed) psa - prostate-specific antigen (total psa) results for one patient sample from cobas e601 analyzer serial number (b)(4).The specific date of testing was not provided.Refer to the medwatch with patient identifier (b)(6) for the free psa assay.The initial results were free psa 8.72 ng/ml and total psa 0.82 ng/ml.The repeat results were free psa 8.72 ng/ml and total psa 0.815 ng/ml.On (b)(6) 2015, the service personnel ran the sample a third time and the results were free psa 9.31 ng/ml and total psa 0.80 ng/ml.As the customer had another similar case, the customer sent the sample to be tested on an abbott and siemens centaur analyzer.Both of the results were a total psa greater than the free psa result.No specific data was provided.The laboratory's results and the results from the centaur were reported to their customer.Information concerning if the patient was adversely affected was requested, but was not provided.No action was taken based on the customer's results.As the sample could not be provided for further investigation, a specific root cause could not be determined.As the results for both assays were reproducible, interference in the sample was possible.Based on the provided calibration and qc data, a general reagent or system issue was not indicated.

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: asku.

• 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: 4731551
• MDR Text Key: 15320568
• Report Number: 1823260-2015-03309
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 04/16/2015
• 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