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

Catalog Number 03289788190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2015

Event Type  malfunction  

Event Description

The customer complained of erroneous results for 1 patient sample tested for free psa (free psa).The results were reported outside of the laboratory.The initial free psa result was 3.79 ng/ml.The total (free + complexed) psa - prostate-specific antigen (tpsa) - (total psa) result was 0.543 ng/ml.The sample was repeated and the free psa result was 3.83 ng/ml.The total psa result was 0.556 ng/ml.On (b)(6) 2015 the sample was tested on a different e601 analyzer and the free psa result was 3.86 ng/ml.The total psa result was 0.674 ng/ml.The sample was also tested on an architect analyzer where the free psa result was 0.624 ng/ml.The total psa result was 1.079 ng/ml.No adverse event occurred.The cobas e601 analyzer serial numbers were not provided.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

A specific root cause could not be identified.The patient sample could not be provided for investigation.Based on the available data, there is no indication of an issue with the system or the reagent.

• Brand Name: FREE PSA
• Type of Device: TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4936613
• MDR Text Key: 6011329
• Report Number: 1823260-2015-03858
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P000027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/02/2015

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: 05/30/2016
• Device Catalogue Number: 03289788190
• Device Lot Number: 183535
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 07/23/2015
• 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
• Patient Age: 068 YR