BEUDAMED
    FDA Adverse Event Death Summary report: N

    CD1800 ANALYZER

    MDR report key: 1032538 · Received April 22, 2008

    Report

    Report Number
    2919069-2008-00513
    Event Type
    Death
    Date Received
    April 22, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 25, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IN 2008, THE CUSTOMER STATES, THAT A PT SAMPLE TESTED USING A CELL-DYN 1800 ANALYZER GENERATED THE FOLLOWING RESULTS: WBC=2.6 K/UL, HGB=10.1 G/DL AND PLT=27 K/UL. THE PT STATED, THAT HE WAS NOT FEELING WELL AND WAS ADMITTED TO HOSPITAL THE SAME DAY. SCHEDULED CHEMOTHERAPY WAS POSTPONED. ONE DAY LATER, BLOOD TESTS WERE ORDERED AT THE HOSPITAL AND RELEASED OBTAINING THE FOLLOWING RESULTS: WBC=2.7 K/UL, HGB=6.9 G/DL AND PLT=20 K/UL. THE CUSTOMER STATES, THAT THE PT RECEIVED 3 UNITS OF PACKED RED BLOOD CELLS ON THE SAME DAY. SIX DAYS LATER, THE CUSTOMER REPORTED THAT THE PT HAD EXPIRED. THE CUSTOMER HAD NO ADD'L INFO REGARDING THE DATE AND CAUSE OF DEATH, BUT STATED THAT THE LIKELY CAUSE WAS RELATED TO DISEASE PROCESS AS A RESULT OF CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R LOT NO. UNK| CD18 CNF HGB LYSE REAGENT LIST NO. 7H84-02