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

Catalog Number 03289788190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for one patient sample tested for total prostate-specific antigen (tpsa) and free prostate-specific antigen (fpsa).The fpsa results were higher than the tpsa results.This medwatch will refer to fpsa.Please refer to the medwatch with patient identifier (b)(6) for information related to tpsa.A prior event for the same patient was previously reported in manufacturer report number 1823260-2015-03864.The sample initially resulted as 0.937 ng/ml when tested for tpsa on an e601 analyzer and it resulted as 6.44 ng/ml when tested for fpsa on an e411 analyzer.The sample was repeated on (b)(6) 2016, resulting as 0.920 ng/ml when tested for tpsa on an e601 analyzer and resulting as 6.41 ng/ml when tested for fpsa on an e411 analyzer.The tpsa result of 0.920 ng/ml and the fpsa result of 6.44 ng/ml were reported outside of the laboratory.The patient was not adversely affected.The serial numbers of the used e601 and e411 analyzers were asked for, but not provided.A specific root cause could not be determined based on the provided information.The sample was requested for investigation, but there was not sufficient volume of the sample remaining for investigation.

• 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 0457
• 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: 5751067
• MDR Text Key: 48307933
• Report Number: 1823260-2016-00818
• 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,u
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 06/27/2016

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: 02/28/2017
• Device Catalogue Number: 03289788190
• Device Lot Number: 18843601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 06/27/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1