BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3123182 · Received May 21, 2013

    Report

    Report Number
    1061932-2013-00856
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED A PINHOLE IN THE BLUE STRIPE TUBING THROUGH PINCH VALVE PV43. THE FSE INDICATED THAT THE TUBING CARRIES WASTE AND DILUENT AND THE HOLE WAS A RESULT OF WEAR FROM THE PINCH VALVE. THE FSE REPLACED THE TUBING AT PV43 TO RESOLVE THE LEAK AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A PINHOLE IN BLUE STRIPE TUBING THROUGH PINCH VALVE PV43. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DILUENT AND CLEANER LEAK OF APPROXIMATELY 6 ML UNDER THE LEFT HAND SIDE OF THE LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS 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
    223779 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1