BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1700

    MDR report key: 410432 · Received August 9, 2002

    Report

    Report Number
    2919069-2002-00007
    Event Type
    Other
    Date Received
    August 9, 2002
    Date of Event
    July 22, 2002
    Report Date
    August 8, 2002
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002, THE ACCOUNT REPORTED A CBC WITH THE FOLLOWING RESULTS: WBC = 3,800/UL, RBC = 1.88X10E6/UL, HGB = 5.6 G/DL, HCT = 16.8%, MCV = 89.6, PLT = 128,000/UL. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A POSSIBLE BLOOD TRANSFUSION. THE HOSPITAL OBTAINED THE FOLLOWING CBC RESULTS: WBC=7,790/UL, RBC = 4.3X10E6/UL, HGB = 13.1 G/DL, HCT = 40.1%, MCV = 93.3, PLT = 277, 000/UL. BASED ON THE HOSPITAL CBC RESULTS THE PATIENT WAS NOT GIVEN A TRANSFUSION AND WAS RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1700 AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR