BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 1971663 · Received January 27, 2011

    Report

    Report Number
    1061932-2011-00039
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IN AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO 2-3 DROPS OF CONTROL MATERIAL OOZING FROM THE CAP OF THE 5C ABN II TUBE. THE CUSTOMER REPORTED NO INJURY OR EXPOSURE/CONTACT TO EYE, SKIN, OPEN WOUNDS, OR MUCUS MEMBRANE OCCURRED. THE CUSTOMER WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT. MEDICAL TREATMENT WAS NOT SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER HEMATOLOGY ANALYZER, GKZ BECKMAN COULTER INC. HMX AL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1