BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1200 ANALYZER

    MDR report key: 278053 · Received May 15, 2000

    Report

    Report Number
    2919069-2000-00010
    Event Type
    Other
    Date Received
    May 15, 2000
    Date of Event
    April 13, 2000
    Report Date
    May 12, 2000
    Manufacturer
    ABBOTT DIAGNOSTICS DIV/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 04/13/2000 THE ACCOUNT REPORTED A HEMOGLOBIN(HGB)=6.8 G/DL AND HEMATOCRIT(HCT)=20.4 FROM A MICROSAMPLE. THE PHYSICIAN ORDERED ANOTHER COMPLETE BLOODCELL COUNT A FEW MINUTES LATER AND THE HGB WAS 13.1 G/GL AND THE HCT WAS 38.8. THERE WAS NO IMPACT TO PT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1200 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIV/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR