BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX WORK AREA MANAGEMENT SYSTEM (MDDS)

    MDR report key: 5072249 · Received September 11, 2015

    Report

    Report Number
    1000515253-2015-00007
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Date of Event
    February 15, 2015
    Report Date
    September 10, 2015
    Manufacturer
    SYSMEX AMERICA INC.
    Product Code
    OUG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    WAM IS A MEDICAL DEVICE DATA SYSTEM THAT RECEIVES DATA FROM SYSMEX HEMATOLOGY ANALYZERS. THERE IS NO FAILURE OF THE ANALYZER. WAM APPLIES THE DILUTION FACTOR TO THE SELECTED RUN CHOSEN BY THE OPERATOR. CODING DEFECT 621 APPLIES THE DILUTION FACTOR CORRECTLY TO THE DILUTION RUN AND INCORRECTLY TO THE PREVIOUS RUN. THIS ALTERS THE ORIGINAL RESULTS OF SOME PARAMETERS FROM THE PREVIOUS RUN. THE VALUES FROM THE PREVIOUS RUN AND DILUTION RUNS ARE DISPLAYED SIDE BY SIDE ON THE RERUN SCREEN. RESULTS POST DILUTION MUST BE MANUALLY VALIDATED AND RELEASED BY THE OPERATOR. VALIDATED RESULTS ARE NOT AFFECTED BY THIS DEFECT. BECAUSE THE ORIGINAL RESULTS ARE MULTIPLIED BY THE DILUTION FACTOR THERE IS A REMOTE POSSIBILITY THE OPERATOR MAY NOT RECOGNIZE THE ALTERED RESULTS AND RELEASE TO THE CLINICIAN. A PATCH FOR THIS DEFECT WAS DEVELOPED AND IS PENDING RELEASE. A SHORT TERM CORRECTIVE ACTION IS TO INFORM OPERATORS TO PERFORM DILUTION CALCULATIONS MANUALLY. DILUTIONS ARE PERFORMED AS PART OF INVESTIGATION AND VALIDATION OF RESULTS OF ABNORMAL SAMPLES THEREFORE INITIAL RESULTS ARE KNOWN. DILUTION FACTORS APPLIED SIGNIFICANTLY CHANGE TEST RESULTS (2X, 3X, 5X ETC.) MAKING THE EFFECTS OF THE DEFECT OBVIOUS TO THE USER.

    Description of Event or Problem · 1

    THE USER OF A SYSMEX WORK AREA MANAGEMENT (WAM) SYSTEM MIDDLEWARE VERSION 5.0 (SERIAL NUMBER (B)(4)) CONNECTED TO AN XN9000 CONFIGURATION WITH TWO XN-10 AUTOMATED HEMATOLOGY ANALYZERS REPORTED TO THE WAM TECHNICAL ASSISTANCE CENTER (TAC) THAT ON (B)(6) 2015 SAMPLE ID (B)(6) REQUIRED A DILUTION FOR A WHITE BLOOD CELL BODY FLUID RESULT VALUE THAT EXCEEDED LINEARITY. (B)(6) INITIAL ANALYSIS GENERATED THE FOLLOWING OP ALERTS: RED BLOOD CELL BODY FLUID (RBCBF) LOW: ADD RERUN AND VERIFY WITH REPEAT ANALYSIS. (REPEAT RBCBF WAS ANALYZED ON THE 2ND RUN). WHITE BLOOD CELL BODY FLUID (WBCBF) LINEARITY: DILUTE, RERUN AS BF, AND CALCULATE WITH DILUTION FACTOR. ( REPEAT FOR THE WBCBF WAS ANALYZED ON THE 3RD RUN.) THE OPERATOR SELECTED THE 3RD RUN AND APPLIED A DILUTION FACTOR OF 3.000. THE OPERATOR NOTED UNEXPECTEDLY THAT WAM APPLIED THE DILUTION FACTOR OF 3.000 TO THE RESULT VALUE FOR RBCBF IN THE 2ND RUN. THE MODIFICATION OF VALUES BY WAM WAS OBVIOUS TO THE OPERATOR; THEREFORE NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. DILUTION RESULTS REQUIRE REVIEW PRIOR TO BEING REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601282 SYSMEX WORK AREA MANAGEMENT SYSTEM (MDDS) MIDDLEWARE OUG SYSMEX AMERICA INC. WAM V.5.0

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Death| O