BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMX AUTOLOADER

    MDR report key: 2140228 · Received June 26, 2011

    Report

    Report Number
    1061932-2011-00745
    Event Type
    Malfunction
    Date Received
    June 26, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. FSE CLEARED THE PORTS ON THE RINSE BLOCK AND ADJUSTED THE ALLEN HEX SET SCREW ABOVE RINSE BLOCK TO ALLOW RINSE BLOCK TO TRAVEL FURTHER DOWN THE PROBE FOR BETTER WIPE COVERAGE AND APPLIED SUCTION TO ABATE DRIPPING OF MANUAL PROBE DURING THE POST WASH/RINSE OF SPECIMEN CYCLE. ROOT CAUSE FOR THE MANUAL PROBE LEAK IS ATTRIBUTED TO THE RINSE BLOCK TRAVEL NOT BEING AT COMPLETE EXTENSION. PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT 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) TO REPORT THAT THE MANUAL PROBE OF THE HMX AUTOLOADER WAS LEAKING BLOODY DILUENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) INCLUDING A LAB COAT, GLOVES AND GOGGLES AT TIME OF OCCURRENCE. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANE AND MEDICAL ATTENTION WAS NOT SOUGHT. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HMX AUTOLOADER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. HMX AUTOLOADER NA

    Patients

    Seq Age Sex Outcome Treatment
    1