BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD 1800 ANALYZER

    MDR report key: 573365 · Received January 26, 2005

    Report

    Report Number
    2919069-2005-00008
    Event Type
    Other
    Date Received
    January 26, 2005
    Date of Event
    December 28, 2004
    Report Date
    January 24, 2005
    Manufacturer
    ABBOTT DIAGNOSTIC DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CONTACTED WITH REGARD TO PT HEMOGLOBIN AND HEMATOCRIT VALUES NOT MATCHING WHEN GENERATED ON A CELL-DYN 1800 ANALYZER. AN INITIAL HGB=7.8 G/DL AND HCT 34.0% WAS OBTAINED. THE SAMPLE WAS REPEATED ON ANOTHER CELL-DYN 1800 ANALYZER YIELDING HGB=11.6 G/GL AND HCT=34.7% WHICH WERE REPORTED. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTIC DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN 07H84-01 CD18 CNF HGB LYSE REAGENT