BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX WORK AREA MANAGER SYSTEM

    MDR report key: 6248138 · Received January 12, 2017

    Report

    Report Number
    1000515253-2017-00002
    Event Type
    Injury
    Date Received
    January 12, 2017
    Date of Event
    December 9, 2016
    Report Date
    January 12, 2017
    Manufacturer
    SYSMEX AMERICA INC.
    Product Code
    OUG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    WAM IS A MEDICAL DEVICE DATA SYSTEM THAT RECEIVES DATA FROM SYSMEX HEMATOLOGY ANALYZERS. THE USER ULTIMATELY IS RESPONSIBLE FOR WORKFLOW, AND FOR USING SYSMEX INSTRUMENTATION, MIDDLEWARE AND ANY INTERNAL LIS ACCORDING TO DIRECTIONS. INVESTIGATION INTO THIS INCIDENT DEMONSTRATED THAT THE WAM MIDDLEWARE WORKED AS INTENDED. THE CRITICALLY LOW RESULT FOR THE HGB PARAMETER WAS CONSIDERED ACCURATE. ACCORDING TO THE WAM V4.1 AND V4.1.1 USER MANUAL, THE OPERATOR MUST VALIDATE THE CBC OR ALL (CBC + AUTO DIFF) FIRST IF THERE ARE CRITICAL RESULTS AND THE CRITICAL POP-UP BOX IS REQUIRED TO BE DOCUMENTED PRIOR TO SIGNING OUT THE SLIDE ON THE DM96. PROPER WORKFLOW IS FOR THE OPERATOR TO VALIDATE THE SAMPLE RESULTS IN WAM FIRST BEFORE VALIDATING THE DM96 RESULTS WHICH WOULD THEN ALLOW BOTH THE CBC RESULTS FROM THE WAM AND THE DIFFERENTIAL RESULTS FROM THE DM96 TO BE RELEASED TO THE LIS TOGETHER. THE USER FAILED TO FOLLOW PROPER WORKFLOW BY VALIDATING THE DIFFERENTIAL RESULTS PRIOR TO VALIDATING RESULTS IN THE WAM. IT IS UNKNOWN IF THE OPERATOR RAN A PENDING LOG BETWEEN THE TIME OF SAMPLE ANALYSIS AND THE TIME THE RESULT WAS REPORTED TO THE CLINICIAN. THE PATIENT'S HEIGHT AND WEIGHT AT THE TIME OF THE INCIDENT WAS REQUESTED; HOWEVER, THE INITIAL REPORTER REFUSED TO PROVIDE THE INFORMATION.

    Description of Event or Problem · 1

    SAMPLE ID (B)(6) WAS ANALYZED ON (B)(6) 2016 AT 10:46PM AND RESULTS FROM A HEMATOLOGY ANALYZER WERE TRANSMITTED TO THE WAM MIDDLEWARE SYSTEM. THE SAMPLE WAS FLAGGED FOR NUCLEATED RED BLOOD CELL (NRBC?) AND ANEMIA. THE SAME SAMPLE WAS REANALYZED THE FOLLOWING DAY AT 12:23 AM WITH AN ANEMIA FLAG AND RESULTS WERE TRANSMITTED TO THE WAM. A CRITICAL LOW HGB RESULT OF 6.6 G/DL WAS ALLEGED BY THE OPERATOR. NO DATA WAS PROVIDED TO CONFIRM SAMPLE RESULT. A SMEAR REVIEW WAS ORDERED FOR THE SAMPLE TO VERIFY RESULTS. A SMEAR WAS MADE AND ANALYZED ON THE USER'S CELLAVISION DM96 AUTOMATED CELL IMAGING SYSTEM. THE OPERATOR REVIEWED AND VALIDATED THE DIFFERENTIAL RESULTS ON THE DM96; HOWEVER, THE PATIENT'S CBC RESULTS IN WAM WERE NEVER VALIDATED. THEREFORE, THE DM96 DIFFERENTIAL RESULTS WERE RELEASED TO THE LABORATORY INFORMATION SYSTEM (LIS) WHILE THE CBC RESULTS (INCLUDING THE HGB) WERE LEFT PENDING IN WAM TO BE VALIDATED BY THE OPERATOR. THE OPERATOR VALIDATED AND RELEASED THE CBC RESULTS TO THE CLINICIAN ON (B)(6) 2016 AT 9:30AM. UPON RELEASE OF THE RESULTS, THE CLINICIAN SENT THE PATIENT TO THE HOSPITAL FOR TRANSFUSION. THE OPERATOR FOLLOWED IMPROPER WORKFLOW RESULTING IN DELAYED REPORTING OF THE PATIENT'S CBC RESULTS TO THE CLINICIAN WHICH DELAYED TREATMENT. THE EXACT DATE/TIME OF THE TRANSFUSION WAS NOT PROVIDED SINCE THE TRANSFUSION TOOK PLACE AT A DIFFERENT UNKNOWN FACILITY. THERE WAS NO KNOWN HARM TO THE PATIENT ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28596 SYSMEX WORK AREA MANAGER SYSTEM MIDDLEWARE OUG SYSMEX AMERICA INC. V 4.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Other