BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESPHERE WORKFLOW SOLUTION

    MDR report key: 16342111 · Received February 9, 2023

    Report

    Report Number
    1000515253-2023-00001
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    January 10, 2023
    Report Date
    February 9, 2023
    Manufacturer
    SYSMEX AMERICA INC.
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THIS ISSUE IS DUE TO AN INCORRECTLY CODED CALCULATION FOR WBC CORRECTION USED WHEN A CUSTOMER HAS ENABLED THE "ALLOW SELECTION OF WBC CORRECTION" SETTING AND WHEN PERFORMING WBC CORRECTION FROM MANUAL DIFFERENTIAL WHEN NRBC IS PRESENT AND WHEN WBC MANUAL DIFFERENTIAL COUNT IS > OR < 100. THIS SOFTWARE MALFUNCTION WAS CAUSED BY IMPROPERLY CODED SOFTWARE (DESIGN OUTPUT) AND DIFFERS FROM THE APPROVED SOFTWARE DESIGN REQUIREMENT (DESIGN INPUT). THE REQUIREMENT, WHICH WAS REVIEWED AND APPROVED BY THE CWS TECHNICAL OWNER, WAS WRITTEN CORRECTLY (TO CALCULATE USING THE "COUNT PER 100" VALUE IN THE CORRECTION CALCULATION). THIS SOFTWARE DESIGN REQUIREMENT WAS VERIFIED IN ACCORDANCE WITH SYSMEX'S PRODUCT DESIGN AND DEVELOPMENT PROCESS ONLY TESTING THE VALUE OF 100, WHICH DOES NOT ALTER THE CORRECTION RESULTS. THE SPECIFIC WORKFLOW AND SET OF CONDITIONS WHICH CREATES THIS ISSUE WAS NOT COVERED IN THE SCOPE OF INTERNAL VERIFICATION OR VALIDATION FOR CWS'S INITIAL PRODUCT RELEASE. A PRODUCT NOTIFICATION WILL BE RELEASED BY THE END OF FEBRUARY 2023. THE USER WILL BE PROVIDED THREE SHORT TERM MITIGATION OPTIONS UNTIL THE PRODUCT ISSUE IS RESOLVED. THE ISSUE WILL BE CORRECTED IN THE SOFTWARE APPLICATION CODING IN THE PRODUCT'S NEXT APPLICATION RELEASE (V1.7.0 - TARGET RELEASE JUNE, 2023). THIS RELEASE WILL PROCESS THROUGH SYSMEX'S INTERNAL PRODUCT DESIGN AND DEVELOPMENT PROCESSES, INCLUDING IDENTIFICATION OF REQUIREMENTS, VERIFICATION AND VALIDATION TESTING (INCLUDING REGRESSION TESTING), AND PRODUCTION READINESS ACTIVITIES.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE USER OF CWS VERSION 1.6.1-2 REPORTED THAT THE WHITE BLOOD CELL (WBC) CORRECTION FOR NUCLEATED RED BLOOD CELLS (NRBCS) USES 100 CELLS, DESPITE THE USER COUNTING 200 CELLS IN THE MANUAL DIFFERENTIAL. THIS ISSUE WAS IDENTIFIED DURING EMULATOR TESTING IN THE CUSTOMER'S TEST (TEST) ENVIRONMENT. INITIAL CUSTOMER INFORMATION WAS CAPTURED AND REPORTED AS A LOWER PRIORITY AS THE ISSUE WAS OCCURRING IN THE CUSTOMER'S TEST ENVIRONMENT. THE ISSUE WAS ESCALATED TO DEVELOPMENT TEAM FOR FURTHER INVESTIGATION. ON (B)(6) 2023, THE DEVELOPMENT TEAM FURTHER ASSESSED THE ISSUE AND DETERMINED THE SOFTWARE CALCULATION FOR CORRECTION WAS NOT FUNCTIONING AS EXPECTED. DURING THE ASSESSMENT, THE TEAM DISCOVERED THE ISSUE ALSO EXISTED IN THE PRODUCTION (PROD) ENVIRONMENT FOR ALL VERSIONS (V1.0.0.0 THROUGH V1.6.1.-2), AND THAT THERE IS POTENTIAL FOR PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067734 CARESPHERE WORKFLOW SOLUTION SYSMEX CWS JQP SYSMEX AMERICA INC. CARESPHERE WORKFLOW SOLUTION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown