MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA; PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Catalog Number 08791732190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of a questionable elecsys total psa immunoassay result for two patients due to interference.Patient 1: the patient had a prostatectomy in 2014 (probably in december).On (b)(6) 2022, the initial result was 0.494 ng/ml and was reported outside of the laboratory.On (b)(6) 2022, the repeat result was 0.475 ng/ml.A separate sample collected on (b)(6) 2022 and repeated three times had a result of < 0.14 ng/ml.This was the expected result for the patient as the previous result for the patient in 2021 was < 0.14 ng/ml.Patient 2: the patient had a probable prostatectomy.The result from a sample in (b)(6) 2021 was < 0.014 ng/ml.The second sample collected in (b)(6) 2021 had a result of 0.446 ng/ml.The repeat result in (b)(6) 2022 was 0.360 ng/ml.The specific dates of testing were not provided.A third sample collected in (b)(6) 2022 had a result of <0.014 ng/ml.This was the expected result for the patient.The questionable results were reported outside of the laboratory.The customer used cobas e 801 module serial number (b)(4).

Manufacturer Narrative

As no sample material could be provided for further investigation, the cause of the event could not be determined.The investigation did not identify a product problem.Based on the data and information provided, a general reagent issue can be excluded.

• Brand Name: ELECSYS TOTAL PSA
• Type of Device: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
• 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: 14117496
• MDR Text Key: 298203939
• Report Number: 1823260-2022-01056
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 07613336165980
• UDI-Public: 07613336165980
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P990056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

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: 10/31/2022
• Device Catalogue Number: 08791732190
• Device Lot Number: 55047201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 06/24/2022
• Supplement Dates FDA Received: 07/15/2022
• 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
• Treatment: PATIENT 1: SUPERDIET QUATUOR
• Patient Age: 69 YR
• Patient Sex: Male