BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD4000 110V

    MDR report key: 597567 · Received August 2, 2004

    Report

    Report Number
    2919069-2004-00058
    Event Type
    Other
    Date Received
    August 2, 2004
    Date of Event
    June 28, 2004
    Report Date
    July 29, 2004
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL/DYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATED THAT THE CD4000 ASPIRATED A SAMPLE INCORRECTLY. THE INSTRUMENT GAVE A "MIXHEAD FAILED TO DESCEND" AND A "MIXHEAD FAILED TO HOME" ERROR. THE SAMPLES WERE REPEATED AND THE ACCOUNT DETERMINED THAT THE SAMPLE IN RACK/TUBE POSITION 26/05 HAD RESULTS WHICH MATCHED THE RESULTS FROM THE SAMPLE IN RACK/TUBE POSITION 26/06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD4000 110V AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELL/DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR