BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX WORK AREA MANAGEMENT SYSTEM

    MDR report key: 3522800 · Received November 6, 2013

    Report

    Report Number
    3009711478-2013-00014
    Event Type
    Other
    Date Received
    November 6, 2013
    Date of Event
    October 8, 2013
    Report Date
    October 30, 2013
    Manufacturer
    SYSMEX AMERICA INC.
    Product Code
    GKZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYZER PRODUCED CORRECT RESULTS. ANY SAMPLE RUN ON AN INSTRUMENT FOR WHICH WAM DOES NOT HAVE AN ORDER, IS AN UNREGISTERED SAMPLE. THE USER CONFIRMED THAT THEIR HEMATOLOGY ANALYZER PROCESSED THE UNREGISTERED SAMPLE ID "(B)(6)" ON (B)(6) 2013. THE USER ALSO CONFIRMED THAT THEY MONITOR THEIR UNREGISTERED LIST AND DELETE THE SAMPLE OR PROCESS THEM IN WAM ON A DAILY BASIS. WHEN SAMPLES ARE DELETED FROM THE UNREGISTERED LIST IN WAM VERSION 2.0, IT DOES NOT DELETE THE SAMPLE FROM THE DATABASE. THE USER REPORTED THAT THE FACILITY IS UPGRADING TO WAM 4.1 IN (B)(4) 2013. WHEN SAMPLES ARE DELETED FROM THE UNREGISTERED LIST IN WAM 4.1, THE SAMPLES ARE ALSO DELETED FROM THE DATABASE. WAM IS USED IN CONJUNCTION WITH AUTOMATED ANALYZERS AS PART OF A SCREENING PROTOCOL TO IDENTIFY ABNORMALITIES IN PT SAMPLES; RESULTS ARE USED IN CONJUNCTION WITH OTHER CLINICAL SIGNS AND SYMPTOMS IN DIAGNOSING AND TREATMENT WHEN NECESSARY. THE USER IS RESPONSIBLE FOR WORKFLOW AND UNDERSTANDING HOW THE ANALYZER AND MIDDLEWARE OPERATE SUCH THAT ERRONEOUS RESULTS ARE NOT RELEASED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT WHILE USING SYSMEX WORK AREA MANAGEMENT (WAM) VERSION 2.0, MIDDLEWARE, A PT WAS GIVEN A BLOOD TRANSFUSION BASED ON INCORRECT LOW HEMOGLOBIN (HGB) RESULT. THE PT'S DIAGNOSIS AND DEMOGRAPHIC INFO ARE UNK. ON (B)(6) 2013 THE TECH ENTERED A SAMPLE ID (SID) INTO THE AUTOMATED HEMATOLOGY ANALYZER WITHOUT THE LEADING "9" DIGIT; THE TECH ENTERED "(B)(6)" INSTEAD OF "(B)(6)". WHEN THE ANALYZER'S RESULTS FOR SID "(B)(6)" TRANSFERRED TO WAM, THE SID WAS EXPANDED WITH LEADING ZERO "(B)(6)". BECAUSE THERE WAS NO ORDER FOR SID (B)(6) WAM REGARDED THE SAMPLE AS "UNREGISTERED". THE TEST RESULTS HAVE NO ORDER OR PT DEMOGRAPHICS AND REMAINED UNREGISTERED IN THE DATABASE. ON (B)(6) 2013 THE LIS SENT AN ORDER WITH A SID OF (B)(6); AND THIS ORDER MATCHED UP WITH THE UNREGISTERED SAMPLE RESULTS FROM (B)(6) 2013 IN THE WAM DATABASE AND DISPLAYED THESE RESULTS. THE RESULTS WERE FLAGGED AND HELD IN WAM, BUT THE LABORATORY TECH VALIDATED/RELEASED THE RESULTS. THE PT'S PREVIOUS HGB RESULT ON (B)(6) 2013 WAS 9.9; THEN ON (B)(6) 2013 HGB RESULT FROM THE UNREGISTERED SID "(B)(6)" WAS RELEASED WITH A HGB RESULT OF 7.4. WHEN THE ATTENDING PHYSICIAN NOTED THE HGB RESULTS HAD FALLEN FROM 9.9 TO 7.4 THE PT WAS GIVEN A BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574067 SYSMEX WORK AREA MANAGEMENT SYSTEM MIDDLEWARE GKZ SYSMEX AMERICA INC. MOLIS WAM V. 2.0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other