BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD 3500CS

    MDR report key: 293544 · Received August 28, 2000

    Report

    Report Number
    2919069-2000-00016
    Event Type
    Other
    Date Received
    August 28, 2000
    Date of Event
    July 26, 2000
    Report Date
    August 24, 2000
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT RAN A COMPLETE BLOOD CELL COUNT IN CLOSED MODE AND REPORTED A HEMOGLOBIN OF 7.4G/DL. THE PT WAS REDRAWN 6 HOURS LATER AND THE COMPLETE BLOOD CELL COUNT WAS RUN IN OPEN MODE. THE HEMOGLOBIN WAS 14.3G/DL. THERE WAS NO IMPACT TO PT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD 3500CS AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR