BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD1700 CS

    MDR report key: 481771 · Received August 29, 2003

    Report

    Report Number
    2919069-2003-00021
    Event Type
    Other
    Date Received
    August 29, 2003
    Date of Event
    July 31, 2003
    Report Date
    August 29, 2003
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT PT RESULTS GENERATED ON THE CELL-DYN 1700 ANALYZER DO NOT CORRELATE WITH MANUAL DIFFERENTIAL SLIDES. THE CUSTOMER STATES THAT PTS DRAWN FOR ROUTINE BLOOD WORK ARE GENERATING HEMOGLOBIN RESULTS IN THE 70 TO 80 G/L RANGE. ALSO, A PT WITH KNOWN HEMOCHROMATOSIS, WHO USUALLY GENERATES HEMOGLOBIN VALUES AT 190 G/L, TODAY GENERATED A RESULT OF 110 G/L. NO RESULTS WERE REPORTED FROM THE LAB. NO ERROR CODES OR ALERT FLAGS WERE GENERATED. CONTROLS WERE IN SPECIFICATIONS. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.

    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 NO INFO