BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1102021 · Received August 7, 2008

    Report

    Report Number
    1823260-2008-06022
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED LEAK FROM UNDER THE ANALYZER AND ONTO THE FLOOR CREATING A PUDDLE. THIS LEAK ALSO DRIPPED ONTO ELECTRICAL COMPONENTS BEHIND THE INSTRUMENT. NO PATIENT SAMPLES INVOLVED. NO ADVERSE EVENTS REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE WASTE PUMP AND REPLACED THE PUMP.

    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