BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3022239 · Received March 26, 2013

    Report

    Report Number
    1061932-2013-00429
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PROBE WIPE FOR THE SECONDARY MODE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE PROBE WASH WHILE RUNNING PROBE WASH TEST INVOLVING AN LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT 1 ML OF FLUID LEAKED ONTO THE COUNTERTOP. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, GLOVES AND GOGGLES AND NO EXPOSURE OR INJURY WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE PROBE WIPE FOR THE SECONDARY MODE WAS NOT PERFORMING TO SPECIFICATIONS. THE FSE REMOVED AND REPLACED ALL 6 TUBES AT PINCH VALVE PV49 AS A PRECAUTION SINCE THE FSE WAS UNABLE TO DETERMINE WHICH OF THE 6 TUBES CAUSED THE LEAK. ALL 6 TUBINGS ARE ACTIVE FOR THE PROBE WIPE FUNCTIONS. THE FSE ALSO CLEANED AND FLUSHED ALL TUBINGS FOR THE RINSE BLOCK AND REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE IS ATTRIBUTED TO THE PROBE WIPE FOR THE SECONDARY MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124387 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1