MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA IMMUNOASSAY; TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER

Catalog Number ASKU

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The sample from (b)(6) 2019 was submitted for investigation.Investigations are ongoing.

Event Description

The initial reporter complained of discrepant results for 1 patient tested for elecsys free psa immunoassay (free psa) and elecsys total psa immunoassay (total psa) on a cobas 8000 e 602 module compared to the abbott architect method.This medwatch will cover total psa.Refer to medwatch with patient identifier (b)(6) for information on the free psa results.The initial roche results were reported outside of the laboratory where they were questioned by the doctor.There was no allegation that an adverse event occurred.The e602 module serial number was (b)(4).

Manufacturer Narrative

The sample from (b)(6) 2019 was sent to an external laboratory and tested by the siemens method with a total psa result of 3.15 ng/ml and a free psa result of 0.10 ng/ml.The sample from (b)(6) 2019 was tested at the investigation site on an e801 module and the customer's observation was reproduced.The sample from (b)(6) 2019 underwent interference testing where there was strong evidence for the presence of endogenous interfering substances that would considerably decrease the total psa results.Additional interference testing suggests the presence of a rare psa-isoform that cannot be completely detected by the standard total psa assay.These issues are addressed in product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." "it is known that in rare cases psa isoforms do exist which may be measured differently by different psa tests.Findings of this kind have occasionally been reported for psa tests from various manufacturers." the investigation did not identify a product problem.

• Brand Name: ELECSYS TOTAL PSA IMMUNOASSAY
• Type of Device: TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8650500
• MDR Text Key: 146492404
• Report Number: 1823260-2019-01997
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 05/09/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR