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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they received questionable results for a total of 50 patient samples tested for total prostate-specific antigen (tpsa) and free prostate-specific antigen (fpsa) tested on an e601 analyzer.Data was provided for a total of three patient samples and of these three samples, two had erroneous results for tpsa and fpsa.The fpsa results were higher than the tpsa results.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.The units of measure used for the tpsa and fpsa assays were asked for, but not provided.This medwatch will cover fpsa.Please refer to the medwatch with patient identifier (b)(6) for information related to tpsa.The first sample resulted as 0.118 for fpsa and 0.005 for tpsa on (b)(6) 2015.The second sample resulted as 0.118 for fpsa and 0.010 for tpsa on (b)(6) 2015.The patients were not adversely affected.The e601 analyzer serial number was (b)(4).A specific root cause could not be determined based on the provided information.The patient samples were requested for investigation, but could not be provided.

Manufacturer Narrative

The units of measure used for the tpsa and fpsa assays are ng/ml.

• 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: 5441201
• MDR Text Key: 38345931
• Report Number: 1823260-2016-00172
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2016

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 Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2016
• 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