BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1241665 · Received November 19, 2008

    Report

    Report Number
    1823260-2008-08553
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 19, 2008
    Manufacturer
    ROCHE INSTRUMENT CENTER AG TEGIMENTA
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTED A LEAK COMING FROM THE ANALYZER. THE LEAK SPREAD ONTO THE FLOOR AND INTO A WALKWAY. NO ONE WAS INJURED AND NO PTS WERE INVOLVED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A DEFECTIVE WASH STATION. HE REPLACED THE WASH STATION. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK