BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD1700 CS

    MDR report key: 234783 · Received August 3, 1999

    Report

    Report Number
    2919069-1999-00015
    Event Type
    Other
    Date Received
    August 3, 1999
    Date of Event
    July 1, 1999
    Report Date
    July 30, 1999
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 07/01/1999 THE ACCOUNT REPORTED A HGB=6.0 G/DL AND HCT=17.5% FOR A PATIENT SAMPLE WAS TESTED AND A HGB=11.3G/DL AND HCT=32.6% WERE OBTAINED. NO TREATMENT WAS GIVEN BASED UPON THE REPORTED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1700 CS AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR