BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 25191208 · Received May 15, 2026

    Report

    Report Number
    1823260-2026-01932
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIQ
    UDI-DI
    04015630919536
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 4000 C311 STAND-ALONE SYSTEM. PATIENT 1: THE INITIAL RESULT WAS 862 MG/L WITH AN ALARM. THE REPEATED RESULT WAS 83 MG/L WITH AN ALARM. THE CUSTOMER COULD NOT DETERMINE THE CORRECT VALUE. PATIENT 2: ON (B)(6) 2026, THE INITIAL RESULT WAS 308 MG/L, AND THE REPEATED RESULT WAS 155 MG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243795 TOTAL PROTEIN URINE/CSF GEN.3 TURBIDIMETRIC, TOTAL PROTEIN JIQ ROCHE DIAGNOSTICS 89434401 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female