BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1200097 · Received October 15, 2008

    Report

    Report Number
    1823260-2008-07619
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OPERATOR REPORTS LEAK COMING FROM BEHIND THE ISE UNIT OF THE ANALYZER AND INTO THE FLOOR. THE USER COVERED UP AND CONTAINED THE LEAK ON THE FLOOR. NO PATIENT SAMPLES WERE INVOLVED AND THE OPERATOR WAS NOT HARMED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE MAIN WASTE COMPARTMENT WAS BLOCKED AND CLEANED THE WASTE COMPARTMENT. HE VERIFIED ANALYZER OPERATION BY RUNNING THE ISES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK