BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD1700 CS

    MDR report key: 522951 · Received February 6, 2004

    Report

    Report Number
    2919069-2004-00006
    Event Type
    Other
    Date Received
    February 6, 2004
    Date of Event
    January 5, 2004
    Report Date
    February 4, 2004
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    QUESTIONABLE CBC RESULTS WERE OBTAINED ON A FINGERSTICK SAMPLE RUN ON THE CD1700. THE INITIAL RESULTS WERE: WBC=21,400/UL (R FLAGS WERE PRESENT ON DIFFERENTIAL), RBC=2.72X10E6/UL, HGB=7.9G/DL, PLT=454,000/UL. THE SAMPLE WAS REPEATED WITH: WBC=30,600/UL (R FLAGS PRESENT), RBC=4.21X10E6/UL, HGB=11.6G/DL, PLT=749,000/UL. THE ACCOUNT STATED THEY MIXED THE SAMPLE A COUPLE OF TIMES AND DID NOT CHECK THE SAMPLE FOR CLOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1700 CS AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR