BEUDAMED
    FDA Adverse Event Other Summary report: N

    FC 500 WITH CXP SW V. 2.2

    MDR report key: 959108 · Received April 23, 2007

    Report

    Report Number
    1061932-2007-00018
    Event Type
    Other
    Date Received
    April 23, 2007
    Date of Event
    March 7, 2007
    Report Date
    April 23, 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
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS CONFIRMED BY THE SOFTWARE DEVELOPERS, APPLIED CYTOMETRY SYSTEMS (ACS/OEM MFR). THIS ONLY AFFECTS EXTERNAL WORKLIST (EWL) FILES CREATED ON THE CELL PREP SYSTEM AND OPENED ON THE CXP ACQUISITION SOFTWARE VERSION 2.2. WORKLISTS OR INDIVIDUAL PANELS OPENED IN CXP ACQUISITION MANAGER DO NOT EXHIBIT THIS PROBLEM. WHENEVER SAMPLE ID1 IS EDITED FOR TUBE 1 IN A PANEL, OR A PANEL IN A WORKLIST, THE REMAINING TUBES IN THE PANEL ARE AUTOMATICALLY UPDATED TO MATCH THE EDITED SAMPLE ID1 AND ALL TUBES IN THE PANEL HAVE THE SAME SAMPLE ID1. BASED ON INVESTIGATION, THE FOLLOWING FACTORS ARE CONSIDERED TO HELP THE OPERATOR IN IDENTIFYING THE ISSUE: THE SAMPLE ID1 FIELD OF THE SUBSEQUENT TUBES NOT UPDATED WILL BE VISIBLE TO THE OPERATOR WHEN THE FIRST TUBE IS EDITED. THE OPERATOR IS CAUTIONED BY THE CUSTOMER MANUAL TO "BE SURE TO VERIFY ANY MANUALLY ENTERED SAMPLE IDS." (CXP ONLINE HELP). THE USER IS ALSO CAUTIONED AT SEVERAL POINTS IN THE USER DOCUMENTATION TO "VERIFY ALL SAMPLE IDS BEFORE REPORTING RESULTS". IF THE OPERATOR PRINTS A FLOWPAGE OF THE INDIVIDUAL RUNS THAT CONSTITUTED THE PANEL, EACH PAGE, TAKEN ON ITS OWN COULD SERVE AS A SOURCE OF PT MIS-IDENTIFICATION. AS A PART OF REGULAR QC, THE RESULTS MUST BE COMPARED BETWEEN THE PRINT-OUTS OF THE PANEL. IN ADDITION, THE SOFTWARE USES THE RUN NUMBER AND THE ANALYSIS TIME AS UNIQUE IDENTIFIERS AND COULD BE USED TO RESOLVE ANY POTENTIAL CONFUSION. BASED ON WORK CONDUCTED BY ACS, THE SOURCE OF THE ERROR WAS DETERMINED TO BE A SOFTWARE DEFECT.

    Description of Event or Problem · 1

    DURING AN INTERNAL TESTING CONDUCTED BY MFR TECHNICAL SUPPORT EMPLOYEE IT WAS REPORTED THAT A PT MIS-IDENTIFICATION OCCURRED ON THE FC 500 INSTRUMENT WITH CXP SOFTWARE VERSION 2.2. WHEN AN EXTERNAL WORKLIST (EWL) FILE, GENERATED BY THE CELL PREP SYSTEM IS OPENED IN CXP SOFTWARE, VERSION 2.2 AND THE SAMPLE ID 1 FIELD IS EDITED IN TUBE 1 OF A MULTI-TUBE PANEL IN AN EWL FILE, THE REMAINING TUBES IN THE PANEL ARE NOT UPDATED AUTOMATICALLY. THE SOFTWARE WILL NOT UPDATE THE SAMPLE ID 1 FIELD IN THE SUBSEQUENT TUBES IN THAT PANEL AS IT SHOULD. AS A RESULT, THE PANEL WILL HAVE TWO DIFFERENT SAMPLE ID 1S: ONE ID1 ASSOCIATED WITH THE EDITED FIRST TUBE. ANOTHER ID 1 FOR THE UNEDITED SUBSEQUENT TUBES IN THE PANEL. PT RESULTS WERE NOT GENERATED IN THIS EVENT SINCE THE EVENT WAS DISCOVERED IN-HOUSE AND NO PT SAMPLES WERE TESTED AT THE TIME. THERE WAS NO EFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FC 500 WITH CXP SW V. 2.2 GENERAL PURPOSE EQUIP LABELED OR PROMOTED FOR A SPECIFIC MED LXG BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA