BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1700

    MDR report key: 718742 · Received November 18, 2005

    Report

    Report Number
    2919069-2005-00073
    Event Type
    Other
    Date Received
    November 18, 2005
    Date of Event
    October 25, 2005
    Report Date
    November 17, 2005
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CELL DYN 1700 ANALYZER GENERATED A HEMOGLOBIN (HGB) RESULT OF 6.6 G/DL AND A HEMATOCRIT (HCT) RESULT OF 20.4% WHICH WAS QUESTIONED AND SETN TO ANAOTHER LAB WHICH OBTAINED A HGB OF 12.8 G/DL AND A HCT OF 37.1% THERE WAS NO OMPACT TO PT MANAGEMENT AS THE LOW RESULT WAS NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN