BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FC 500 WITH CXP SOFTWARE

    MDR report key: 953967 · Received November 21, 2007

    Report

    Report Number
    1061932-2007-00056
    Event Type
    Malfunction
    Date Received
    November 21, 2007
    Date of Event
    October 26, 2007
    Report Date
    November 21, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LXG
    PMA / PMN Number
    K030828
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FLOW CYTOMETRY TECHNICAL SUPPORT INDICATES THAT IN FLOW CYTOMETRY APPLICATIONS, ALL THE INFO PERTINENT TO A SAMPLE ARE SENT OVER IN A SINGLE TRANSMISSION AS EACH SAMPLE IS RUN AND THUS WOULD NOT BE SUSCEPTIBLE TO THIS ERROR. FOR THIS ISSUE TO OCCUR THE USER WOULD HAVE TO SPECIFICALLY CREATE SPECIMEN MANAGEMENT RULES THAT PULLS INDIVIDUAL DATA FROM A RUN, PERFORM A CALCULATION ON THESE DATA ELEMENTS AND THEN RERUN THE SAMPLES AND PERFORM THE SAME RULE AGAIN WITH THE INTENT OF COMPUTING THE RESULTS FROM THE NEW RUN DATA. AS AN EXAMPLE: SAMPLE "BOB" IS RUN PRODUCING DATA ELEMENTS A1, B1, C1. SOME OTHER "REFERENCE" SAMPLE IS RUN PRODUCING DATA ELEMENT R. SM RULE IS WRITTEN SUCH THAT THE FUNCTION R X A1 IS EXECUTED. SAMPLE "BOB" IS RERUN PRODUCING DATA ELEMENTS A2, B2, C2. THE SM RULE IS RERUN WITH THE INTENT OF PRODUCING RXA. WHAT IS PRODUCED INSTEAD IS R X A1. THE USER MUST TEST THE SPECIMEN MANAGER RULES THAT THEY CREATE FOR CORRECT CALCULATION RESULTS PER THE DATA INNOVATIONS INSTRUMENT MANAGER USER DOCUMENTATION. THE FC500 INSTRUMENT WITH CXP SOFTWARE EXECUTES THE CALCULATIONS FOR THE TRACKING ASSAYS AS WELL AS FOR ALL IVD APPLICATIONS AND SENDS THESE TO THE DI INSTRUMENT MANAGER IN A SUMMARIZED PANEL REPORT. NO FURTHER CALCULATIONS ARE THEREFORE NECESSARY. SERVICE WAS NOT DISPATCHED FOR THIS ISSUE AS IT WAS DISCOVERED BY THE SOFTWARE MANUFACTURER AND DISTRIBUTED TO ALL OF THEIR CUSTOMERS VIA A BULLETIN. NO CUSTOMER COMPLAINTS HAVE BEEN RECEIVED. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE A SOFTWARE DEFECT THAT INCORRECTLY HANDLES TEST RESULTS SEQUENCE.

    Description of Event or Problem · 1

    DATA INNOVATIONS INSTRUMENT MANAGER, VERSIONS 8.05 AND 8.06, SPECIMEN MANAGEMENT SOFTWARE FOR USE WITH THE FC500 FLOW CYTOMETRY SYSTEM WITH CXP SOFTWARE IS A FEATURE OF INSTRUMENT MANAGER THAT ALLOWS THE USER TO VISUALLY DISPLAY INFO ABOUT PT, SPECIMEN AND TEST INFO, INCLUDING TEST RESULTS THAT HAVE BEEN HELD FOR VERIFICATION, PREVIOUS RESULTS AND IMAGES. BECKMAN COULTER INC. (BCI) RECEIVED A REPORT FROM THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) STATING THAT: "CUSTOMERS USING DATA INNOVATION INSTRUMENT MANAGER SOFTWARE VERSIONS 8.05 AND 8.06 AND SPECIMEN MANAGEMENT RULES (SM RULES). WHEN MULTIPLE RESULTS ARE RECEIVED FOR A GIVEN TEST FROM THE SAME INSTRUMENT THAT ARE CONTAINED IN SEPARATE MESSAGES FOR THE SAME SPECIMEN ID, SM RULES INCORRECTLY RETRIEVES THE OLDEST RELEASED TEST RESULT RATHER THAN THE MOST RECENT RELEASED TEST RESULT VALUE. NOTE: SM RULES CALCULATIONS ARE PERFORMED CORRECTLY WHEN ALL TESTS BEING EVALUATED IN A RULE ARE RECEIVED IN A SINGLE MESSAGE FROM THE INSTRUMENT. THIS IS TRUE WHETHER IT IS THE FIRST INSTANCE OF THE RESULT OR IF THE SPECIMEN HAS BEEN RERUN MULTIPLE TIMES." NO PT RESULTS WERE PRODUCED. THIS ISSUE WAS RAISED BY THE DATA INNOVATIONS CORPORATION IN THE FORM OF A BULLETIN TO ALL OF THEIR CUSTOMERS. BASED ON AVAILABLE INFO, THERE WAS NO IMPACT TO PT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FC 500 WITH CXP SOFTWARE GENERAL PURPOSE EQUIPMENT LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE LXG BECKMAN COULTER, INC. AC T DIFF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR