BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3241842 · Received July 22, 2013

    Report

    Report Number
    1061932-2013-01552
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TOT HE CUSTOMER'S SITE. THE FSE DISCOVERED THAT THE INSTRUMENT WAS LEAKING DILUENT WHEN RINSING THE PROBE. UPON FURTHER EVALUATION, THE FSE DISCOVERED THAT THE PROBE RINSE BLOCK WAS COMING DOWN TOO FAR AND THE FSE PROCEEDED TO ADJUST THE TRAVEL OF THE PROBE RINSE BLOCK TO RESOLVE THE ISSUE. THE FSE DID NOT OBSERVE ANY FURTHER LEAKS AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. RESULTS: FAILURE MODE OF THE LEAK IS ATTRIBUTED TO THE PROBE RINSE BLOCK REQUIRING ADJUSTMENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE PROBE RINSE BLOCK OF THE LH 500 HEMATOLOGY ANALYZER WHILE RUNNING IN MANUAL (SECONDARY) MODE. THE CUSTOMER REPORTED THAT APPROXIMATELY 1 ML OF FLUID LEAKED AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER REPORTED THAT THE LEAK IS CLEAR BUT SOMETIME TINTED WITH BLUE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, PERSONAL EYEWEAR, AND A LABORATORY COAT AT THE TIME OF THE LEAK AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339874 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1