BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD FACSCANTO & LOADER W/ BD FASCDIVA SOFTWARE

    MDR report key: 590118 · Received April 1, 2005

    Report

    Report Number
    2916837-2005-00001
    Event Type
    Other
    Date Received
    April 1, 2005
    Date of Event
    March 3, 2005
    Report Date
    March 31, 2005
    Manufacturer
    BD BIOSCIENCES
    Product Code
    GKZ
    Removal / Correction Number
    2916387-3/31/05-001/C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER WAS RUNNING TWO PT SAMPLES WITH THREE TUBES EACH. THE CUSTOMER STOPPED THE CAROUSEL MANUALLY. THE SOFTWARE THEN PROMPTED THE CUSTOMER TO RE-ASSIGN THE CAROUSEL IDENTIFICATION BUT DID NOT ALERT HIM THAT THE POSITION OF THE TUBES HAD BEEN CHANGED IN THE CAROUSEL SETUP WINDOW. THE CAROUSEL WAS THEN RESTARTED WITHOUT MANUALLY REORDERING THE TUBES IN THE CAROUSEL. THE CUSTOMER NOTICED THAT THE SECOND PT ID HAD BEEN REASSIGNED TO THE FIRST SPECIMEN. THE CUSTOMER NOTICED THE ISSUE PRIOR TO REPORTING ANY RESULTS OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD FACSCANTO & LOADER W/ BD FASCDIVA SOFTWARE FLOW CYTOMETER GKZ BD BIOSCIENCES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other