BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1172335 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07059
    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
    MEDICAL TECHNOLOGIST

    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 A CLOG IN DRAIN TUBING AT SAMPLE RINSE STATION, AND CLEANED DRAIN TUBING. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS P MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK