BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2¿ ANALYZER

    MDR report key: 2802220 · Received October 23, 2012

    Report

    Report Number
    1061932-2012-02610
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 28, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ASPIRATION PUMP AND RESOLVED THE ISSUE. THE FSE MANUALLY ADJUSTED THE RED BLOOD CELL (RBC), WHITE BLOOD CELL (WBC), HEMOGLOBIN (HGB) AND PLATELET (PLT) CALIBRATION FACTORS TO CONTROLS. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 1061932-2012-02608, 1061932-2012-02609, 1061932-2012-02610, 1061932-2012-02611, 1061932-2012-02612.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LOW WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), HEMOGLOBIN (HGB), HEMATOCRIT (HCT), AND PLATELET (PLT) RESULTS, FOR FIVE PATIENTS, ON SEPARATE DAYS INVOLVING THE COULTER ACT DIFF 2 ANALYZER. THIS IS REPORT THREE OF FIVE. THE REANALYZED RESULTS CORRELATED TO THE CUSTOMER'S EXPECTATION AND WERE CONSIDERED CORRECT. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF 2¿ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1