BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 4000 110V

    MDR report key: 541642 · Received March 25, 2004

    Report

    Report Number
    2919069-2004-00013
    Event Type
    Other
    Date Received
    March 25, 2004
    Date of Event
    February 27, 2004
    Report Date
    March 25, 2004
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE CELL-DYN 4000 ANALYZER GENERATED A PLATELET COUNT OF 19.2 K/UL ON A PT DIAGNOSED WITH ACUTE SEPSIS. NO FLAGS OR WARNING MESSAGES WERE GENERATED ON THE INITIAL RUN WHICH WAS REPORTED OUT OF THE LAB. THE SAMPLE WAS REPEATED YIELDING A PLATELET COUNT OF 58.2 K/UL AND A CORRECTED REPORT WAS SENT OUT. THE PT WAS REDRAWN AND THE SAMPLE YIELDED A PLATELET COUNT OF 22.7 K/UL AND REPEATED AT 26.7 K/UL BUT THE SAMPLE WAS FOUND TO BE CLOTTED SO THE RESULTS WERE NOT REPORTED. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 4000 110V AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN