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

Catalog Number 03289788160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The customer complained of questionable elecsys free psa immunoassay and elecsys total psa immunoassay results for 1 patient sample tested on a cobas e 411 immunoassay analyzer serial number (b)(4).The customer questioned a possible interference in the patient sample.This medwatch will cover the free psa.Please refer to the medwatch with patient identifier (b)(6) for data on the total psa data.The initial total psa result was 0.063 ng/ml with a repeat result of 0.063 ng/ml.The initial free psa result was 0.151 ng/ml with repeat results of 0.154 ng/ml and 0.156 ng/ml.No erroneous results were reported outside of the laboratory.There was no adverse event.The field service engineer (fse) performed an instrument performance check that was acceptable.The instrument was performing within specifications.The investigation is currently ongoing.

Manufacturer Narrative

Based on calibration and qc data a general reagent issue could be excluded.The investigation found issues with the total psa assay.No issue was found with the free psa assay.

• Brand Name: ELECSYS FREE PSA IMMUNOASSAY
• 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
• MDR Report Key: 8147420
• MDR Text Key: 130346573
• Report Number: 1823260-2018-04727
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• PMA/PMN Number: P000027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

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: 03289788160
• Device Lot Number: 00330824
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 11/20/2018
• Supplement Dates FDA Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR