BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 2895428 · Received January 3, 2013

    Report

    Report Number
    1061932-2012-02943
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. THAT THERE WAS A LEAK FROM THE PROBE AND THE MIDDLE SECTION OF THE COULTER ACT DIFF 2 HEMATOLOGY ANALYZER. CUSTOMER REPORTED THE VOLUME OF THE LEAK WAS ABOUT 5 ML. CUSTOMER REPORTED CONTROLS THAT WERE RUN ON THE ACT DIFF 2 ANALYZER RECOVERED WITHIN THE EXPECTED VALUES. CUSTOMER REPORTED PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE WHITE BLOOD CELL BATH WAS OVERFLOWING. THE FSE REPLACED THE PERISTALTIC DRAIN TUBING TO RESOLVE THIS ISSUE. THE FSE REPLACED PINCH VALVE PV11, FLUID FILTERS AND THE PINCH TUBING AT PINCH VALVE PV8 TO RESOLVE THE LEAK IN THE PROBE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2388 COULTER AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1