BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC.T DIFF ANALYZERS

    MDR report key: 2151656 · Received June 24, 2011

    Report

    Report Number
    1061932-2011-00677
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    December 9, 2008
    Report Date
    December 9, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER PRODUCT LABELING: BCI INC. URGES 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. LOCAL SUPPORT HAS SENT CUSTOMER A REPLACEMENT WASTE CONTAINER. BASED ON AVAILABLE INFO, THE ROOT CAUSE FOR LEAKING WASTE CONTAINER IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL BIOHAZARD EVENT WHEN THE WASTE CONTAINER OF THE COULTER ACT DIFF ANALYZERS WAS LEAKING. THE CUSTOMER CONTAINED THE LEAK BY PLACING THE WASTE CONTAINER INTO A CLINICAL WASTE BAG FOR PROPER DISPOSAL. OPERATORS WERE WEARING PERSONAL PROTECTIVE EQUIPMENT, GLOVES AND LAB COAT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC.T DIFF ANALYZERS GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA