BEUDAMED
    FDA Adverse Event Death Summary report: N

    CD4000 110V

    MDR report key: 408943 · Received August 1, 2002

    Report

    Report Number
    2919069-2002-00006
    Event Type
    Death
    Date Received
    August 1, 2002
    Date of Event
    June 26, 2002
    Report Date
    July 31, 2002
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ERRONEOUS CD4000 PLATELET RESULTS OF 40,400/UL AND 36,100/UL WERE REPORTED ON THE DAY OF THE EVENT CAUSING A DELAY IN PLATELET TRANSFUSION FOR A PATIENT. NO VERIFICATION OF RESULTS WERE PERFORMED. THE CUSTOMER STATES THAT A SMEAR WAS REVIEWED, BUT DUE TO TECHNICIAN ERROR, A PLATELET ESTIMATE WAS NOT PERFORMED. ON THE FOLLOWING DAY, CD4000 PLATELET RESULTS OF 37,900/UL AND 24,800/UL WERE REPORTED ON THE PATIENT AND WERE CORRECTED TWO HOURES LATER TO 4,000/UL AND 3,000/UL AFTER SMEAR ESTIMATE WAS PERFORMED. CD3500 PLATELET RESULT WAS 5,400/UL. THE PATIENT WAS GIVEN 20 UNITS OF PLATELETS AND WAS TAKEN TO SURGERY. INTRACRANIAL BLEEDING WAS DETERMINED. THE PATIENT'S PLATELET COUNTS FOLLOWING PLATELET TRANSFUSION WERE 148,000/UL AND 288,000/UL ON CD3500 CONFIRMED BY SMEAR ESTIMATES. THE PATIENT EXPIRED ON 6/30/02.

    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 46 YR Death