BEUDAMED
    FDA Adverse Event Other Summary report: N

    DC1800 ANALYZER

    MDR report key: 610760 · Received June 3, 2005

    Report

    Report Number
    2919069-2005-00039
    Event Type
    Other
    Date Received
    June 3, 2005
    Date of Event
    May 4, 2005
    Report Date
    June 2, 2005
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISCREPANT HEMOGLOBIN (HGB) RESULTS WERE REPORTED FROM THE CELL DYN 1800 ANALYZER ON A FINGERSTICK SAMPLE. THE CELL DYN 1800 RESULTS WERE: HGB=10.5 G/DL. THE PT WAS REPEATED AT THE HOSPITAL USING A VENOUS SAMPLE AND THE HGB RESULT WAS 7.3 G/DL. THE CUSTOMER STATED THAT THEY USUALLY INVERT THE SAMPLE 10 TIMES PRIOR TO RUNNING AND THAT THEY DID NOT CHECK FOR CLOTS PRIOR TO RUNNING. NO ADVERSE IMPACT TO PT MANAGEMENT WAS RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DC1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN