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

Catalog Number	08791732190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).Qc was in range prior to the samples being measured; therefore, a general reagent or analyzer is not present.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable undetectable low elecsys total psa results from the cobas e 801 analytical unit.The number of patients was not specified; results were provided for two patients.Patient 1's initial result was 0.15 ug/l, and the repeat result was 0.01 ug/l, accompanied by a data flag.Patient 2's initial result on (b)(6) 2025 was 1.38 ug/l, with 2 repeat results of 0.01 ug/l, accompanied by a data flag.Another repeat result was 0.006 ug/l, accompanied by a data flag.This repeat result is consistent with the patient's history.It was provided that patient 1 is monitored as they have undergone surgery and occasionally see higher results, but on repeat the result is lower.
Additional Manufacturer Narrative
In the initial medwatch, the second line in h11 additional narrative should have been: "qc was in range prior to the samples being measured; therefore, a general reagent or analyzer problem is not present.Instead of: "qc was in range prior to the samples being measured; therefore, a general reagent or analyzer is not present." no relevant alarms were observed in the provided alarm trace.The field service engineer replaced the measuring cells.There were no further events reported after the service.The investigation was unable to determine a direct root cause.The investigation did not identify a product problem.

• Brand Name: ELECSYS TOTAL PSA
• Common Device Name: 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22675059
• Report Number: 1823260-2025-02361
• Device Sequence Number: 3716419
• Product Code: MTF
• UDI-Device Identifier: 07613336165980
• UDI-Public: 07613336165980
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: P990056/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 08791732190
• Device Lot Number: 827044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown