BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 24005330 · Received January 8, 2026

    Report

    Report Number
    1823260-2026-00109
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 19, 2025
    Report Date
    February 26, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 861352. THE FIELD SERVICE ENGINEER (FSE) CHECKED THE PRE-ANALYTIC INSTRUMENT, THE SAMPLE PROBE, AND THE REACTION CELL. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. NO PRODUCT PROBLEM WAS IDENTIFIED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE BIL-D GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLE AS THE TOTAL BILIRUBIN RESULT WAS ACCOMPANIED BY A DATA FLAG. THE INITIAL RESULT WAS 1.32 MG/DL. THE SAMPLE WAS RECENTRIFUGED, ALIQUOTED INTO A SAMPLE CUP, AND REPEATED. THE REPEAT RESULT WAS 0.0976 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62518 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown