BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF ANALYZER

    MDR report key: 2830800 · Received November 13, 2012

    Report

    Report Number
    1061932-2012-02704
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) INSTRUCTED THE CUSTOMER TO CLEAN THE PROBE WIPE. THE CUSTOMER CLEANED THE PROBE WIPE AND THE LEAK WAS FIXED. THE CUSTOMER RAN SAMPLES AND VERIFIED THAT THE LEAK WAS REPAIRED. NO SERVICE WAS DISPATCHED AS THE CUSTOMER CORRECTED THE ISSUE. FAILURE MODE: THE CAUSE OF THE LEAK WAS THAT THE PROBE WIPE WAS DIRTY. PER COULTER ACT DIFF ANALYZER OPERATOR'S GUIDE, PN (B)(4): WARNINGS AND PRECAUTIONS: 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) REPORTING A LEAK AT THE PROBE IN THE COULTER AC-T DIFF ANALYZER. THE VOLUME OF THE LEAK WAS A FEW DROPS AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES AND LABCOAT AT THE TIME THE LEAK WAS DISCOVERED. NO ONE CAME IN CONTACT WITH THE FLUID. MEDICAL ATTENTION WAS NOT SOUGHT. NO PATIENT RESULTS WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. AC*T DIFF N/A

    Patients

    Seq Age Sex Outcome Treatment
    1