BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 23223927 · Received October 6, 2025

    Report

    Report Number
    1823260-2025-04075
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 12, 2025
    Report Date
    February 25, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIQ
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE CUSTOMER SUSPECTS AN INTERFERING FACTOR IN THE PATIENT SAMPLE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    SECTION A2 AND A3 WERE UPDATED, AS WELL AS PATIENT MEDICATIONS. CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025. THE QC RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. BASED ON THE CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH A PATIENT SAMPLE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FOR 1 PATIENT URINE SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS A NEGATIVE PROTEIN RESULT WAS EXPECTED. THE INITIAL RESULT WAS 93.8 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER C503 ANALYZER IN ANOTHER LABORATORY AND THE RESULT WAS 93.8 MG/DL. THE SAMPLE WAS REPEATED AGAIN ON A U601 ANALYZER AND THE RESULT WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478076 TOTAL PROTEIN URINE/CSF GEN.3 URINE/CSF TOTAL PROTEIN TEST JIQ ROCHE DIAGNOSTICS 852901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown