BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 INSTRUMENT

    MDR report key: 2115945 · Received June 8, 2011

    Report

    Report Number
    1061932-2011-00593
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 8, 2011
    Report Date
    May 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND ADJUSTED THE TUBE FORWARDING SENSOR. HE ALSO REPLACED THE NEEDLE. AS PER PRODUCT LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT WHILE RUNNING A SAMPLE IN THE AUTOMATIC MODE OF THE COULTER LH 500 INSTRUMENT, THE STOPPER CAME OFF THE PURPLE TOP 5ML EDTA TUBE CAUSING BLOOD TO SPILL ON THE ROCKERBED AND FLUID TO LEAK FROM THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. THERE WAS NO EXPOSURE, OR CONTACT WITH THE EYES OR SKIN, OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 INSTRUMENT AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1