BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTO LOADER

    MDR report key: 2873167 · Received December 13, 2012

    Report

    Report Number
    1061932-2012-02822
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND EXAMINED THE SYSTEM. THE FSE FOUND A LOOSE BLOOD SAMPLING VALVE (BSV) KNOB WHICH CAUSED THE MIGRATION OF CLENZ FROM THE BSV PADS. THE FSE TIGHTENED THE LOOSE BSV KNOB. THE ISSUE WAS RESOLVED. THE INSTRUMENT WAS THEN TESTED AND VERIFIED TO MEET PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE COULTER HMX HEMATOLOGY ANALYZER LEAKED APPROXIMATELY 1ML OF BLUE LIQUID AT THE BLOOD SAMPLING VALVE (BSV). THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE OCCURRENCE. THERE WERE NO INJURIES OR EXPOSURES TO ANY LABORATORY PERSONNEL. NO ERRONEOUS RESULTS WERE GENERATED BY THE INSTRUMENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE FACILITY TO EXAMINE THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTO LOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1