BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3801286 · Received May 8, 2014

    Report

    Report Number
    1061932-2014-01015
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE FOUND THERE WAS A PLUG IN THE NEEDLE WASTE LINE. HE RESOLVED THE ISSUE BY BLEACHING THE LINE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SOME SAMPLE AND DILUENT LEAKED ONTO THE CAPS OF THE TUBES WHILE RUNNING THE LH780 INSTRUMENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. IN ADDITION, THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278777 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1