BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF ANALYZER

    MDR report key: 2842606 · Received November 21, 2012

    Report

    Report Number
    1061932-2012-02722
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OF A LEAK COMING FROM THE PROBE OF THE COULTER AC*T DIFF ANALYZER. THE CUSTOMER INDICATED THAT THEY HAD RECENTLY CHANGED THE PERI PUMP TUBING. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LAB COAT AND NO EXPOSURE OR INJURY WAS REPORTED. CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO DRAIN THE INSTRUMENT AND VERIFY IF THE PERI PUMPS WERE WORKING. THE CUSTOMER THEN TRIED TO RUN A SAMPLE AND NOTED THAT 1 TO 2 ML OF FLUID HAD LEAKED FROM THE PROBE AND ONTO THE COUNTER. THE CUSTOMER ALSO STATED THAT HIGH BACKGROUNDS ON WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), HEMOGLOBIN (HGB) AND PLATELET (PLT) RESULTS WERE OBSERVED. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THE EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED A DEFECTIVE PINCH VALVE (LV10) AND CHECK VALVE TO VACUUM ISOLATION CHAMBER (VIC) DRAIN. INSTRUMENT WAS THEN VERIFIED AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE IS DETERMINED TO BE A DEFECTIVE LV10 AND CHECK VALVE TO VIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1