BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1172337 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07058
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED A WATER LEAK COMING FROM THE ANALYZER ONTO THE FLOOR. NO ONE WAS HARMED AND NO PATIENT SAMPLES WERE INVOLVED. THE FIELD SERVICE REPRESENTATIVE FOUND THE INCUBATION BATH OVERFLOWING APPARENTLY CAUSED BY ANALYZER SETTING SINCE INSTALLATION. HE RE-LEVELED ANALYZER, PERFORMED INCUBATION BATH WATER EXCHANGE AND MONITORED SYSTEM FOR LEAKS DURING ANALYZER OPERATION WITH NO ADDITIONAL LEAKS OBSERVED. PERFORMANCE TESTS WERE PERFORMED.

    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