BEUDAMED
    FDA Adverse Event Other Summary report: N

    CYTOMICS FC500-MPL WITH MXP SOFTWARE

    MDR report key: 854581 · Received May 22, 2007

    Report

    Report Number
    1061932-2007-00028
    Event Type
    Other
    Date Received
    May 22, 2007
    Date of Event
    April 25, 2007
    Report Date
    May 22, 2007
    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

    Additional Manufacturer Narrative · 1

    THIS ISSUE DOES NOT AFFECT QC SINCE CYTOSETTINGS ARE NOT IMPORTED. PER THE TSR, DURING A NORMAL WORKFLOW, A CLINICIAN PLACES THE INSTRUMENT IN A "SET-UP" MODE TO ADJUST SETTINGS BEFORE RUNNING PATIENT SAMPLES. ONCE THE PROPER SETTINGS ARE DONE, THE INSTRUMENT WOULD BE PLACED IN A NORMAL RUN MODE AND THE SOFTWARE WOULD AUTOMATICALLY RESET BEFORE RUNNING PATIENT SAMPLES. THIS EFFECT WOULD THEREFORE NOT BE SEEN ONCE SAMPLES RUNS HAVE BEGUN AS NO FURTHER CHANGES TO THE CYTOSETTINGS WOULD BE MADE. THIS ISSUE DOES NOT AFFECT LOCKED PROTOCOLS AS STEM OR TETRA. HOWEVER, IT COULD AFFECT ANY UNLOCKED APPLICATIONS AS LEUKOSURE APPLICATION PROTOCOLS WHERE THERE IS A POTENTIAL FOR ERRONEOUS RESULTS TO BE PRODUCED. THIS ISSUE WAS FOUND TO AFFECT ALSO THE CURRENT MXP VERSION 2.1 SOFTWARE. THE ROOT CAUSE OF THE PROBLEM WAS DETERMINED TO BE A SOFTWARE DEFECT WHICH WILL BE CORRECTED IN THE UPCOMING VERSION.

    Description of Event or Problem · 1

    WHILE CONDUCTING AN IN-HOUSE TESTING ON THE UPCOMING MXP SOFTWARE VERSION 2.2, BECKMAN COULTER INC. (BCI) TECHNICAL SUPPORT REP (TSR) DISCOVERED A SOFTWARE ISSUE: WHEN ACQUIRING DATA FROM A PROTOCOL, AN OPERATOR CAN CHOOSE TO GET/IMPORT CYTOSETTINGS FROM ANOTHER LIST MODE FILE. IF THE ALREADY DISPLAYED DATA IS NOT REFRESHED AS IT SHOULD, THIS CAUSES THE INSTRUMENT TO OUTPUT RESULTS, WHICH ARE DERIVED FROM A COMBINATION OF THE TWO CYTOSETTINGS RATHER THAN THE NEWLY IMPORTED SETTINGS AS IT SHOULD. THE HISTOGRAMS AND PRINTOUTS RESULTS ARE GENERATED FROM BOTH, AN OLD AND THE NEW CYTOSETTINGS. THIS DATA IS NOT REPRESENTATIVE OF EITHER CYTOSETTINGS, BUT RATHER A COMBINATION OF THE TWO AND IS THEREFORE, ERRONEOUS. A PRINTOUT OF THE RUN WILL SHOW THE CUMULATIVE DATA AND ERRONEOUSLY IMPLY THAT THE NEWLY IMPORTED CYTOSETTINGS PRODUCED IT. FURTHER REVIEW OF THIS PROBLEM BY TSR INDICATES THAT THE SAVED RUNTIME DATA (LIST MODE FILE) WILL ALSO CONTAIN THIS CUMULATIVE DATA AS WELL. THE TSR INDICATED THAT PATIENT RESULTS WERE NOT AFFECTED IN THIS EVENT SINCE IT OCCURRED DURING AN INTERNAL TESTING, AND NO PATIENT RESULTS WERE RELEASED AT THE TIME. THERE WAS NO AFFECT TO PATIENT OR USER RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYTOMICS FC500-MPL WITH MXP SOFTWARE GENERAL PURPOSE LABORATORY EQUIPMENT LABELED OR PROMOTED FOR A SPECIFIC MEDICAL LXG BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Other