BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1213177 · Received October 23, 2008

    Report

    Report Number
    1823260-2008-07849
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 4, 2008
    Report Date
    October 23, 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 LEAK FROM UNDERNEATH AND IN FRONT OF THE ANALYZER ONTO THE FLOOR. NO PATIENT SAMPLES WERE INVOLVED. NO ONE HAS BEEN INJURED. THE FIELD SERVICE REP COULD NOT DUPLICATE THE LEAK TO DETERMINE THE CAUSE OR SOURCE, BUT NOTED HE CHECKED THE ANALYZER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK