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

Catalog Number 03289788190

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/26/2014

Event Type  malfunction  

Manufacturer Narrative

A root cause could not be determined with the information provided.There was not enough patient sample to perform an investigation.

Event Description

The customer alleged they received questionable free prostate-specific antigen (fpsa) and total prostate-specific antigen (tpsa) results for one patient.The units of measure were requested but not provided.The patient's sample was tested on an analytic e-module (mod04), serial number not provided.The tpsa result was 3.54 and the fpsa result was 4.46.These results were reported outside the laboratory.On (b)(6) 2014, the patient was tested again on mod04.The tpsa result was 3.58 and the fpsa result was 4.40.On (b)(6) 2014, the patient was tested on another e-module (mod06), serial number not provided.The tpsa result was 3.71 and the fpsa result was 4.46.On (b)(6) 2014, the patient was tested on a third e-module (mod02), serial number not provided.The tpsa result was 3.71 and the fpsa result was 4.65.The customer stated this sample was measured on another instrument- abbott architect i4000 and provided the following four sets of results.On (b)(6) 2014 the tpsa result was 0.09 and fpsa result was 2.82.On (b)(6) 2014, the tpsa result was 0.085 and fpsa result was 2.91.With a 1:10 dilution, the tpsa result was 0.07 and fpsa result was 3.75.With a 1:2 dilution, the tpsa result was 0.08 and fpsa result was 3.14.Information on whether any results came from the same patient samples was requested but not provided.Information on whether any results other than the results from (b)(6) 2014 were reported outside the laboratory was requested but not provided.There were no deaths, injuries, illnesses, or deteriorations in health associated with the erroneous results.Information on whether the patient was harmed by any action taken was requested but not provided.The tpsa reagent lot number and expiration date were requested but not provided.The customer provided the serial number (b)(4).Information on which e- module that number belonged to was requested but not provided.

Manufacturer Narrative

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

• Brand Name: FREE PROSTATE-SPECIFIC ANTIGEN
• 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: 3829288
• MDR Text Key: 12021832
• Report Number: 1823260-2014-03653
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 06/24/2014

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: 03289788190
• Device Lot Number: 174624
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 05/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2014
• 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: 073 YR