BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3183395 · Received June 21, 2013

    Report

    Report Number
    1061932-2013-01144
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND CONFIRMED THE LEAK COMING FROM A HOLE IN TUBING AT PINCH VALVE PV37. THE FSE REPLACED THE TUBING TO RESOLVE THE LEAK AND NO FURTHER ISSUES WITH LATRON CONTROL WERE NOTED. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A HOLE IN TUBING AT PINCH VALVE PV37. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CLENZ LEAK AT THE RIGHT SIDE OF THE LH 500 HEMATOLOGY ANALYZER WHILE RUNNING LATRON CONTROL. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND THE CONDUCTIVITY CHANNEL WAS LOW ON THE LATRON CONTROL. THE OPERATOR 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
    282350 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1