BEUDAMED
    FDA Adverse Event Death Summary report: N

    CD4000 110V

    MDR report key: 444280 · Received February 21, 2003

    Report

    Report Number
    2919069-2003-00006
    Event Type
    Death
    Date Received
    February 21, 2003
    Date of Event
    January 19, 2003
    Report Date
    February 20, 2003
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT HAD 2 CD4000 INSTRUMENTS WHICH WERE DOWN. SERVICE WAS DISPATCHED TO THE ACCOUNT AND ARRIVED IN THE MORNING ON THE EVENT DATE. THE ACCOUNT STATED THAT THERE WAS A DELAY IN REPORTING PT RESULTS. ONE PT SPECIMEN WAS SENT TO ANOTHER FACILITY FOR TESTING. ALLEGEDLY THE PT DIED FROM BLEEDING. THE CAUSE OF DEATH WAS NOT REPORTED BY THE FACILITY. IT IS NOT KNOWN IF THE DELAY IN TESTING CONTRIBUTED TO THE DEATH. THE ACCOUNT HAS NOT PROVIDED ANY FURTHER DETAILS RELATED TO THIS INCIDENT.

    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 NO INFO Death CELL-DYN 4000 ANALYZER