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

Catalog Number 08791732190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

Calibration results were acceptable.Quality controls were within the specified ranges.Camera images from the sample collected by the analyzer show a clot or an air bubble, indicating a sample quality issue.Data review further shows multiple sample foam alarms in the last month.The investigation could not identify a product problem.The cause of the event could not be determined.Na.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys total psa assay on a cobas e 801 module, serial number (b)(4).The sample initially resulted in a total psa value of 0.19 ug/l.The result was deemed incorrect.On (b)(6) 2023, the sample was repeated two times, resulting in values of 15.8 ug/l and 15 ug/l.On (b)(6) 2023, the sample was repeated two times, resulting in values of 14.8 ug/l and 15.4 ug/l.No questionable result was reported outside of the laboratory.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16621536
• MDR Text Key: 312073708
• Report Number: 1823260-2023-00987
• 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
• Report Date: 03/27/2023

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: 12/31/2023
• Device Catalogue Number: 08791732190
• Device Lot Number: 652127
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/27/2023
• 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