BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1700

    MDR report key: 534516 · Received March 9, 2004

    Report

    Report Number
    2919069-2004-00009
    Event Type
    Other
    Date Received
    March 9, 2004
    Date of Event
    February 9, 2004
    Report Date
    March 8, 2004
    Manufacturer
    ABBOTT DIAGNOSITCS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT A PT SAMPLE GENERATED QUESTIONABLE RESULTS WHEN TESTED USING A CELL-DYN 1700 ANALYZER. A HEMOGLOBIN RESULT OF 5.6 G/DL AND HEMATOCRIT RESULT OF 16.3% WAS OBTAINED. CONTROLS WERE WITHIN SPECIFICATION. THE RESULTS WERE REPORTED. THE SAMPLE WAS SENT OUT TO A REFERENCE LAB FOR VERIFICATION TESTING (PLATFORM NOT PROVIDED) AND YIELDED A HEMOGLOBIN OF 11.3 G/DL AND HEMATOCRIT OF 32.8%. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1700 AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSITCS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 MO