BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYZER CORE

    MDR report key: 1234076 · Received November 4, 2008

    Report

    Report Number
    1823260-2008-08152
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 13, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OPERATOR REPORTED ANALYZER LEAKING HEAVILY ONTO THE FLOOR. NO PT SAMPLES WERE INVOLVED AND NO OPERATORS WERE HARMED. THE CUSTOMER FOUND A CLOG IN THE SAMPLE PROBE DRAIN AND CLEANED THE DRAIN WHICH RESOLVED THE LEAK. PERFORMANCE TESTS PERFORMED BY CUSTOMER WHICH ARE WITHIN SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYZER CORE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS MODULAR CORE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK