BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1172225 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07060
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 3, 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
    MO, 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 OPERATOR WAS INJURED AND NO PATIENT SAMPLES INVOLVED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE OF THE LEAK TO BE A DAMAGED INTERNAL WATER FILTER AND REPLACED THE WATER FILTER. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I400+

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK