BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 4000 110V

    MDR report key: 251862 · Received November 24, 1999

    Report

    Report Number
    2919069-1999-00022
    Event Type
    Other
    Date Received
    November 24, 1999
    Date of Event
    October 13, 1999
    Report Date
    November 17, 1999
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 10/13/1999, THE ACCOUNT REPORTED A HEMOGLOBIN OF 16.0 G/DL FOR A FINGERSTICK SAMPLE, RUN IN OPEN MODE. FLAGS WERE GENERATED BY THE INSTRUMENT TO WARN THE USER. THE SAMPLE WAS RETESTED ON THE CD4000 ON 10/14/1999 AND A HGB OF 8.97 G/DL WAS OBTAINED. THE SAMPLE WAS RETESTED A THIRD TIME ON 10/14/1999 ON A CD3000 AND A HGB OF 9.1 G/DL WAS OBTAINED. A NEW SAMPLE WAS DRAWN ON 10/14/1999 AND A HEMOGLOBIN OF 9.8 WAS OBTAINED. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 4000 110V AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO