BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 3031780 · Received April 2, 2013

    Report

    Report Number
    1061932-2013-00557
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE DISCOVERED A SMALL AMOUNT (A DROP OR TWO) THAT WAS LEAKING EVERY ASPIRATION FROM THE PROBE WIPE AT THE CLOSED VIAL POSITION. AFTER 4-6 ASPIRATIONS THE FLUID WOULD ACCUMULATE AND RUN DOWN THE CLOSED VIAL MODULE. THE FSE REPLACED THE PROBE WIPE AND VACUUM ISOLATOR CHAMBER, WHICH FIXED THE LEAK. 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 (BEC) REPORTING THAT THE COULTER ACT DIFF 2 HEMATOLOGY ANALYZER WAS LEAKING DILUENT IN THE CAP PIERCE STATION. THE VOLUME OF FLUID WAS A FEW DROPS AND WAS CONTAINED WITHIN THE UNIT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND GOGGLES DURING THE OCCURRENCE OF THIS EVENT. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133679 COULTER AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1