BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 23659510 · Received November 26, 2025

    Report

    Report Number
    1823260-2025-04882
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 22, 2025
    Report Date
    February 6, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIQ
    UDI-DI
    04015630919536
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS INTEGRA 400 PLUS SERIAL NUMBER WAS (B)(6). BASED ON THE PROVIDED DATA, A GENERAL REAGENT PROBLEM COULD BE EXCLUDED BECAUSE CALIBRATION AND QUALITY CONTROL WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED FOR THE DATES OF THE QUESTIONABLE RESULTS. PATIENT 1 OCCURRED ON (B)(6) 2025. PATIENT 2 OCCURRED ON (B)(6) 2025. MEDWATCH FIELD B3 DATE OF EVENT WAS UPDATED.

    Additional Manufacturer Narrative · 0

    DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FROM THE COBAS INTEGRA 400 PLUS ANALYZER. PATIENT 1 INITIAL RESULT WAS 275.03 MG/L, AND THE REPEAT RESULT IN ANOTHER LABORATORY WAS 82.1 MG/L. PATIENT 2 INITIAL RESULT WAS 105.5 MG/L, AND THE REPEAT RESULT IN ANOTHER LABORATORY WAS 68.1 MG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433091 TOTAL PROTEIN URINE/CSF GEN.3 TURBIDIMETRIC, TOTAL PROTEIN JIQ ROCHE DIAGNOSTICS 86777201 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown