BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1172327 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07056
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED LEAK FROM THE ANALYZER THAT DRIPPED OFF OF THE COUNTER AND RAN ONTO THE FLOOR. PATIENT SAMPLES APPEAR TO BE FINE AND NO OPERATORS WERE HARMED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE TWO PLUGS FOR THE WASH TOWER HAD BEEN PIERCED AND REPLACED THE PLUGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK