BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1700

    MDR report key: 535267 · Received March 9, 2004

    Report

    Report Number
    2919069-2004-00010
    Event Type
    Other
    Date Received
    March 9, 2004
    Date of Event
    February 12, 2004
    Report Date
    March 8, 2004
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL ANALYZER
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT A PT SAMPLE WAS ASSAYED WITHIN 5 MINUTES OF BEING DRAWN AND GENERATED THE FOLLOWING RESULTS WHEN USING A CELL-DYN 1700 ANALYZER; WBC=4.9 K/UL, RBC-2.23 M/UL, HGB=6.7 G/DL, HCT=20.6%, PLT=88 K/UL. THE RBC, HCT, AND PLT WERE FLAGGED BY THE INSTRUMENT AS LOW AND THE HGB RESULT WAS FAGGED CR (CRITICALLY LOW). THE RESULTS WERE REPORTED TO A PHYSICIAN. THE PT WAS ADMITTED TO THE HOSP AND A CBC PERFORMED, GENERATING RESULTS IN THE NORMAL RANGE (PLATFORM AND RESULTS NOT PROVIDED). A REPEAT OF THE ORIGINAL SAMPLE ON THE CELL-DYN 1700 YIELDED THE FOLLOWING RESULTS; WBC=9.6 K/UL, RBC=4.50 M/UL, HGB=13.7 G/DL, HCT=42.0%, PLT=200 K/UL. THE REPEATED RESULTS WERE VERY CLOSE TO THAT OF THE HOSPITAL VALUES. NO FURTHER IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR