BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 19756148 · Received July 16, 2024

    Report

    Report Number
    1823260-2024-02055
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 19, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER FACILITY NAME: (B)(6). THE REAGENT LOT NUMBER IS 801069. THE EXPIRATION DATE WAS NOT PROVIDED. IT WAS NOTED THAT THE SAMPLE PROBE WAS DIRTY AND SERUM WAS ON THE SAMPLE PROBE PATH. THE FIELD SERVICE REPRESENTATIVE CHANGED THE SAMPLE PROBE AND ADJUSTED IT. HE ADJUSTED THE CELL RINSE STATION'S LEVELS AND ADJUSTED THE REAGENT CAP PIERCER. THE INVESTIGATION WAS ONGOING.

    Additional Manufacturer Narrative · 0

    AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE RESULTS FOR 3 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. PATIENT 1 (ID: (B)(6): THE INITIAL RESULT WAS 461 MOL. THE REPEATED RESULT WAS 52 MOL/L. PATIENT 2 (ID: (B)(6): THE INITIAL RESULT WAS 285 MOL/L. THE REPEATED RESULT WAS 75 MOL/L. PATIENT 3 (ID: (B)(6): THE INITIAL RESULT WAS 394 MOL/L. THE REPEATED RESULT WAS 95.6 MOL/L. THE SAMPLES WERE REPEATED DUE TO THE INITIAL RESULTS NOT MATCHING THE PATIENTS' CLINICAL HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509347 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown