BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD1700 CS

    MDR report key: 604199 · Received May 16, 2005

    Report

    Report Number
    2919069-2005-00035
    Event Type
    Other
    Date Received
    May 16, 2005
    Date of Event
    April 19, 2005
    Report Date
    May 16, 2005
    Manufacturer
    ABBOTT DIAGNOSTICS DIV/CELL DYN
    Product Code
    GKL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER TECHNICAL ADVOCATE (CTA) AS CONTACTED WITH REGARD TO ERRATIC PT RESULTS GENERATED USING A CELL-DYN 1700 CS ANALYZER. INITIAL TESTING YIELDED WBC=6.0 K/UL, HGB=7.7 G/DL AN PLT=195 K/UL. THE SAMPLE WAS REPEATED WITH THE FOLLOWING RESULTS OBTAINED; WBC=8.8 K/UL, HGB=10.1 G/DL AND PLT=285 K/UL. THIS PT WAS SCHEDULED FOR A BLOOD TRANSFUSION WHICH WAS CANCELLED WHEN A CORRECTED REPORT WAS SENT OUT. NO FURTHER IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1700 CS AUTOMATED HEMATOLOGY ANALYZER GKL ABBOTT DIAGNOSTICS DIV/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR