BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 21718322 · Received March 28, 2025

    Report

    Report Number
    1823260-2025-00915
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    March 5, 2025
    Report Date
    May 6, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIQ
    UDI-DI
    04015630919536
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE IN RANGE ON THE DAY OF THE EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    THE COBAS 8000 COBAS C 502 MODULE SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 18 MG/L, THE FIRST REPEAT RESULT WAS 113 MG/L, AND THE SECOND REPEAT RESULT ON A COBAS PRO WAS 95.1 MG/L. THE SECOND AND THIRD RESULTS ARE DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2614005 TOTAL PROTEIN URINE/CSF GEN.3 TURBIDIMETRIC, TOTAL PROTEIN JIQ ROCHE DIAGNOSTICS 83792401 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown