BEUDAMED
    FDA Adverse Event Other Summary report: N

    FC 500 WITH CXP SW V1.1

    MDR report key: 616381 · Received July 28, 2004

    Report

    Report Number
    1061932-2004-00012
    Event Type
    Other
    Date Received
    July 28, 2004
    Date of Event
    June 30, 2004
    Report Date
    July 28, 2004
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LXG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN INTERNAL INVESTIGATION (IN-HOUSE TESTING OF SOFTWARE) AT BECKMAN COULTER, A POTENTIAL SAMPLE MISIDENTIFICATION WAS DISCOVERED WHEN USING THE FC 500 WITH CXP SOFTWARE VERSION 1.1. A BECKMAN COULTER SENIOR APPLICATIONS SCIENTIST WAS PALYING A LISTMODE FILE (A) THAT WAS GENERATED BY A DOS BASED SOFTWARE (ALTRA) THROUGH A PROTOCAL IN THE CXP SOFTWARE. THE APPLICABLE FCS (FLOW CYTOMETRIC STANDARD) INFO FIELDS WITH THE ASSOCIATED INFO WERE PRESENTED ON THE SCREED ACCURATELY. THE SENIOR APPLICATIONS SCIENTIST PLAYED LISTMODE FILE (B) THAT WAS CREATED BY THE CXP SOFTWARE THROUGH THE SAME PROTOCOL IN THECXP SOFTWARE. THE APPLICABLE FCS INFO FIELDS THAT PREVIOUSLY CONTAINED VALUES FORM LISTMODE FILE A WERE REPLACED BY VALUES FROM LISTMODE B. ANY FCS INFO FIELD S THAT WERE PREVIOUSLY BLANK, BUT WERE APPLICABLE TO LISTMODE B, WERE CORRECTLY POPULATED BY VALUES FROM LISTMODE B. THE SENIOR APPLICATIONS SCIENTIST REPLAYED LISTMODE FILE A THROUGH THE SAME PROTOCOL IN THE CXP SOFTWARE. THE APPLICABLE FCS INFO FIELDS THAT PREVIOUSLY CONTAINED VALUES FROM LISTMODE B WERE REPLACED BY VALUES FROM LISTMODE A. ANY FCS INFO FIELDS THAT WERE SPECIFIC TO LISTMODE B AND PRVIOUSLY POPULATED BY VALUES FROM LISTMODE B REMAINED UNCHANGED, INSTEAD OF BEING "CLEARED". THE SENIOR APPLICATION SCIENTIST REFRESHED THE ONSCREEN DISPLAY VALUES AND THE INFO IN THE FCS INFO FIELDS WERE CORRECTED (LISTMODE B VALES WAS "CLEARED"). THE EVEN T ONLY AFFECTS ONSCREEN DISPLAYED VALUES AND IS CONFINED TO THE FCS INFO VALUES IN THE FCS INFO PLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FC 500 WITH CXP SW V1.1 GENERAL PURPOSE LABORSTORY EQUIPMENT LABELED OR PROMOTED FOR LXG BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * AV Other