BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 4000 110V

    MDR report key: 548547 · Received April 2, 2004

    Report

    Report Number
    2919069-2004-00015
    Event Type
    Other
    Date Received
    April 2, 2004
    Date of Event
    March 10, 2004
    Report Date
    April 2, 2004
    Manufacturer
    ABBOTT LABORATORIES DIV./CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) WAS CONTACTED BY THE ACCOUNT STATING THAT WHEN USING THE CELLDYN 4000 ANALYZER IN CLOSED MODE THAT RACK #10 WILL BE UP ONE POSITION AT RACK/TUBE POSITION#4, SAMPLE THAT PT AND THEN BACK UP ONE POSITION TO RACK/TUBE #3 AND USE THE SAME BARCODE ID AS RACK/POSITION #4. THE ACCOUNT STATED THAT NO OTHER RACKS SHOW THIS EVENT AND THAT THEY ARE NOT RUNNING ASSAYS THAT BACK UP THE RACK AS PART OF THE ROUTINE PROCESS. THE ACCOUNT NOTICED THE EVENT OCCURRING TWICE AND WAS ABLE TO QUESTION THE PRINTOUTS AND NOT RELEASE ANY RESULTS ON THOSE PATIENTS. NO BARCODE LABEL INFORMATION WAS SHARED WITH THE CTA. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 4000 110V AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT LABORATORIES DIV./CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN