BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 23645694 · Received November 25, 2025

    Report

    Report Number
    1823260-2025-04836
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 23, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIQ
    UDI-DI
    04015630919536
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025. THE PROVIDED QC SHOWED RESULTS OUTSIDE THE ACCEPTABLE RANGE. THE ALARM TRACE SHOWED AN ABNORMAL ASPIRATION ALARM. THE CUSTOMER WAS ASSISTED VIA TELEPHONE, AND IT WAS FOUND THAT THE CUSTOMER WAS USING THE INCORRECT CALIBRATOR. THE CUSTOMER PERFORMED CALIBRATION WITH THE REQUIRED CALIBRATOR, PRECISION STUDIES, AND SAMPLE TESTING WITH SUCCESSFUL RESULTS. THE TROUBLESHOOTING ACTION PERFORMED DURING THE CUSTOMER'S ASSISTANCE RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE COBAS C 502 MODULE SERIAL NUMBER WAS (B)(6). THE SAMPLE WAS A URINE SAMPLE. THE CALIBRATION FAILED AFTER THE REAGENT PACK WAS CHANGED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN.3 ASSAY ON A COBAS 8000 COBAS C 502 MODULE. INITIAL RESULT: 19.9 MG/DL. MULTIPLE CALIBRATOR FAILURES PROMPTED THE REPEAT OF THE SAMPLE ON A DIFFERENT ANALYZER. REPEAT RESULT: 8.8 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULT WAS ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2832832 TOTAL PROTEIN URINE/CSF GEN.3 TURBIDIMETRIC, TOTAL PROTEIN JIQ ROCHE DIAGNOSTICS 867772 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown