BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 8/10 ANALYZER

    MDR report key: 2827882 · Received November 12, 2012

    Report

    Report Number
    1061932-2012-02655
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) TROUBLESHOT, WHILE ON THE PHONE, WITH CUSTOMER AND HAD THE CUSTOMER MANUALLY DRAIN THE BATHS USING FUNCTION M12-DRN, BLEACH THE WASTE PATHWAY AND DRAIN USING M12-DRN. THE CUSTOMER RAN RINSE MIX 3 TIMES AND THEY STATED THE BATHS WERE DRAINING PROPERLY. THE CUSTOMER RAN STARTUPS WITH PASSING RESULTS, RAN CONTROLS AND ALL RESULTS RECOVERED IN RANGE. THE CUSTOMER HAD NO FURTHER ISSUES OR QUESTIONS AND THE CALL WAS CLOSED. THE FIELD SERVICE WAS NOT DISPATCHED TO THE CUSTOMER SITE. PER 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC), AND REPORTED A 10 ML LEAK OF CLEAR FLUID COMING FROM THE AT 8/10 ANALYZER, AND THE BATHS WERE OVERFLOWING WHILE RUNNING CONTROLS. THE CUSTOMER WAS WEARING GLOVES AND A GOWN. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO MEDICAL ATTENTION WAS SOUGHT. MSDS WAS REVIEWED. THE FACILITY HAS A RISK MANAGEMENT PLAN. NO DISCREPANT RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT 8/10 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1