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

Catalog Number 08828610190

Device Problem High Test Results (2457)

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

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The patient samples were requested for investigation.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys free psa immunoassay results compared to total psa results for 1 patient on a cobas e 801 analytical unit compared to a siemens analyzer.This medwatch will cover free psa.Refer to medwatch with a1 patient identifier pt (b)(6) for information on the total psa results.On (b)(6) 2024, the patient had a sample tested on module 3 free psa result of 1.23 ng/ml and a total psa result of 0.101 ng/ml.On (b)(6) 2024, the sample was repeated on a siemens analyzer and the free psa result was 0.03 ng/ml and the total psa result was 1.04 ng/ml.On (b)(6) 2024, the patient had a sample tested on module 4 and the free psa result was 1.20 ng/ml and a total psa result of 0.103 ng/ml.On (b)(6) 2024, the sample was repeated on a siemens analyzer and the free psa result was 0.03 ng/ml and the total psa result was 1.00 ng/ml.

Manufacturer Narrative

The investigation did not identify a product problem.The specific cause of the event could not be determined.Based on the provided data, the issue was consistent with the presence of rare endogenous interfering substance(s) in the patient samples.Per product labeling: 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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.

• Brand Name: ELECSYS FREE 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19080577
• MDR Text Key: 340468707
• Report Number: 1823260-2024-01088
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 07613336166628
• UDI-Public: 07613336166628
• Combination Product (y/n): Y
• Reporter Country Code: EG
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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: 08828610190
• Device Lot Number: 73065701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1