BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2930773 · Received January 28, 2013

    Report

    Report Number
    1061932-2013-00097
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF ABOUT 1 ML INSIDE THE LH 500 HEMATOLOGY ANALYZER AND THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO AFFECT OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) FOUND A LEAK AT THE NEEDLE ASSEMBLY AND OBSERVED THAT THE NEEDLE WAS BENT. THE FSE REPLACED THE NEEDLE ASSEMBLY AND THE LEAK WAS RESOLVED. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND FAILURE MODE WAS DETERMINED TO BE THE BENT NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36652 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1