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 Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer experienced an issue where the elecsys free psa immunoassay results were higher than the elecsys total psa immunoassay results for one patient.The customer used cobas e 411 (disk) immunoassay analyzer (b)(4).The free psa result was 3.36 ng/ml and the total psa result was 0.319 ng/ml.The sample was tested in another laboratory by clia.The free psa result was 0.17 ng/ml and the total psa result was 1.17 ng/ml.A second sample was taken from the patient on (b)(6) 2017.The free psa result was 3.81 ng/ml and the total psa result was 0.313 ng/ml.The second sample was tested in another laboratory on another cobas e 411 immunoassay analyzer.The serial number of this analyzer was not provided.The free psa result was 3.40 ng/ml and the total psa result was 0.33 ng/ml.The results were reported outside of the laboratory.There was no allegation of an adverse event.(b)(6).

Manufacturer Narrative

Investigation of the provided calibration data found the customer was using an expired lot of reagent at the time of the event.The analyzer date had been altered to allow the use of the expired reagent.

• 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: 6867973
• MDR Text Key: 86414191
• Report Number: 1823260-2017-01997
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: IR
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2017

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: 05/31/2018
• Device Catalogue Number: 03289788190
• Device Lot Number: 20987702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 08/27/2017
• Supplement Dates FDA Received: 12/18/2017
• 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