BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD4000 110V

    MDR report key: 522934 · Received February 4, 2004

    Report

    Report Number
    2919069-2004-00004
    Event Type
    Other
    Date Received
    February 4, 2004
    Date of Event
    January 8, 2004
    Report Date
    February 2, 2004
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ERRATIC PT RESULTS WERE GENERATED ON CELL-DYN 4000 HEMATOLOGY ANALYZER. THE INITIAL RUN ON A PT RESULTED IN A HEMOGLOBIN RESULT OF 12.3G/DL. A REPEAT RUN ON THE SAME ANALYZER RESULTED IN A HEMOGLOBIN OF 8.08G/DL. THE SAMPLE WAS REPEATED ON ANOTHER CELL-DYN 4000 ANALYZER AND RESULTED IN A HEMOGLOBIN OF 7.92G/DL. THERE WAS NO RESULT FLAGGING OR ERROR MESSAGES GENERATED BY EITHER ANALYZER. THREE LEVELS OF CONTROLS WERE RUN WITH RESULTS IN RANGE. THE 7.92G/DL HEMOGLOBIN RESULT WAS REPORTED. NO ADD'L PT INFO WAS AVAILABLE. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD4000 110V AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN