BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 22650029 · Received July 29, 2025

    Report

    Report Number
    1823260-2025-02337
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 4, 2025
    Report Date
    August 18, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGQ
    UDI-DI
    04015630925179
    PMA / PMN Number
    K071239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS CONSISTENT WITH AN ABNORMAL AND CONSPICUOUS REACTION CAUSED BY THE USAGE OF NON-ROCHE, NOT SUPPORTED PARTNER CHANNELS REAGENTS, LEADING TO AN UNKNOWN CARRY-OVER INTERFERENCE.

    Additional Manufacturer Narrative · 0

    THE COBAS 8000 C702 MODULE SERIAL NUMBER WAS (B)(6). THE SAMPLE AND REAGENT NEEDLES WERE NOT CLEANED REGULARLY, AND THEY WERE ONLY CLEANED WHEN THEY WERE FOUND TO BE DIRTY. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF A DISCREPANT RESULT FOR 1 PATIENT'S URINE SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ASSAY ON A COBAS 8000 C702 MODULE. ON (B)(6) 2025, THE INITIAL RESULT WAS 75 MG/L. ON (B)(6) 2025, A NEW URINE SPECIMEN WAS TAKEN FROM THE PATIENT AND TESTED ON A MINDRAY INSTRUMENT USING THE PYROGALLOL RED MOLYBDENUM METHOD IN A DIFFERENT HOSPITAL, RESULTING IN A URINE TOTAL PROTEIN VALUE OF 24 MG/L; THE ROUTINE URINE TEST WAS NEGATIVE. THE REPORTER DEEMED THE INITIAL RESULT FROM THE MODULE WAS TOO HIGH. ON (B)(6) 2025, THE REPEAT RESULT OF THE INITIAL PATIENT SAMPLE AFTER DILUTION WAS 128 MG/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY, AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE INITIAL RESULT WAS DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061797 TOTAL PROTEIN URINE/CSF GEN.3 TOTAL PROTEIN JGQ ROCHE DIAGNOSTICS 79939501 04015630925179

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Unknown