BEUDAMED
    FDA Adverse Event Other Summary report: N

    FC 500 WITH UPS

    MDR report key: 898368 · Received August 16, 2007

    Report

    Report Number
    1061932-2007-00043
    Event Type
    Other
    Date Received
    August 16, 2007
    Date of Event
    July 20, 2007
    Report Date
    August 16, 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

    IT WAS DETERMINED THAT THIS ISSUE IS CAUSED BY INADEQUATE LABELING: CURRENT LABELING DOES NOT ADEQUATELY INFORM THE USER THAT ANY CHANGES TO PT DEMOGRAPHICS MUST BE PERFORMED AT THE LIS OR THE IM. CURRENT LABELING DOES NOT ADEQUATELY INFORM THE USER OF THE EFFECT OF USING THE SAME SPECIMEN ID WITH MULTIPLE FLUID CODES. HOWEVER, CURRENT PRODUCT LABELING INSTRUCTS THE USER TO VERIFY SAMPLE IDS PRIOR TO REPORTING RESULTS OUT OF THE LAB.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) TECHNICAL SUPPORT DEPARTMENT CONDUCTED AN INTERNAL TESTING ON THE FC 500 INSTRUMENT WITH UPS INTEGRATED WITH THE DATA INNOVATIONS' INSTRUMENT MANGER (IM). (DATA INNOVATIONS' IM IS AN INDEPENDENTLY DEVELOPED SYSTEM). IT WAS DISCOVERED THAT THE INTEGRATION OF THE 2 SYSTEMS CREATES A POTENTIAL RISK THAT WAS NOT ADEQUATELY MIGRATED IN THE LABELING AND A POTENTIAL MISMATCH OF SAMPLE TYPE, RESULTS AND PT DEMOGRAPHICS MAY OCCUR UNDER CERTAIN CIRCUMSTANCES: THE FC500 SOFTWARE PT NAME MIDDLE INITIAL FIELD ALLOWS FOR ONE CHARACTER. DATA INNOVATIONS IM MIDDLE INITIAL FIELD ALLOWS MULTIPLE CHARACTERS. IF A "SPACE" IS USED BEFORE THE MIDDLE INITIAL IN THE IM, THE "SPACE" WILL BE RECOGNIZED AS THE MIDDLE INITIAL IN FC500. AT RESULTS PRINTED AT THE FC500 WILL INCLUDE A PT NAME WITH NO MIDDLE INITIAL. THIS COULD LEAD TO A MISIDENTIFICATION IF ONLY PT NAME IS USED AS THE PRIMARY IDENTIFIER AND THERE WERE 2 PTS PRINTED WITH THE SAME NAME (ALTHOUGH SAMPLE ID 1 WOULD BE UNIQUE). WHEN PT DEMOGRAPHIC FIELDS ARE CHANGED BY THE USER AT THE FC500, THE CHANGES ARE NOT INCORPORATED AT THE IM. THIS COULD LEAD TO A MISMATCH OF PT DEMOGRAPHICS. THE IM DOES NOT ALLOW FOR MULTIPLE FLUID CODES (SAMPLE TYPE IN FC500) FOR THE SAME SPECIMEN ID (SAMPLE ID IN FC500). IF THIS SITUATION OCCURS, THE PT SPECIMEN INFORMATION WILL SHOW THE LATEST FLUID CODE FOR ALL SAMPLES WITH THAT SPECIMEN ID. 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 AFFECT TO PT OR USER AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR