BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD1700 CS

    MDR report key: 603295 · Received May 16, 2005

    Report

    Report Number
    2919069-2005-00033
    Event Type
    Other
    Date Received
    May 16, 2005
    Date of Event
    April 19, 2005
    Report Date
    May 16, 2005
    Manufacturer
    ABBOTT LABORATORIES
    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) WAS CONTACTED WITH REGARD TO ERRATIC PATIENT RESULTS GENERATED USING A CELL-DYN 1700 CS ANALYZER. INITIAL TESTING YIELDED WBC=10.0 K/UL, HGB=8.9G/GL AND PLT=281 K/UL. THE SAMPLE WAS REPEATED WITH THE FOLLOWING RESULTS OBTAINED; WBC=14.6 K/UL, HDB=11.6 G/DL AND PLT=403 K/UL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1700 CS AUTOMATED HEMATOLOGY ANALYZER GKL ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR