BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX WORK AREA MANAGEMENT SYSTEM

    MDR report key: 5596087 · Received April 21, 2016

    Report

    Report Number
    1000515253-2016-00012
    Event Type
    Injury
    Date Received
    April 21, 2016
    Date of Event
    March 25, 2016
    Report Date
    March 28, 2016
    Manufacturer
    SYSMEX AMERICA INC.
    Product Code
    OUG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FUNCTIONALITY OF THE WAM SOFTWARE WAS WORKING AS DESIGNED. IT WAS THE INTENT OF THE APPLICATION TO PREVENT DELETION OF TEST RESULTS THAT WERE NOT A ZERO RESULT OR PENDING IN ORDER TO PREVENT INADVERTENT DELETION OF VALID RESULTS. IT WAS DECIDED TO MODIFY THIS FUNCTIONALITY TO BE ALLOWABLE BY RULE BUT NOT BY MANUAL DELETION THROUGH THE ACTIONS BOX. THE ACTIONS BOX WILL ONLY DELETE TESTS WHEN THE RESULT IS BLANK. A PATCH (WAM5GA13;WAM502GA3) HAS BEEN DEVELOPED TO CREATE THIS CHANGE.

    Additional Manufacturer Narrative · 1

    ON 4/23/2016 THE SOFTWARE TECHNICAL SPECIALIST RECEIVED AN EMAIL FROM THE USER STATING THAT A BONE MARROW BIOPSY WAS NOT PERFORMED ON THE PATIENT BUT A BLOOD LEUKEMIA PANEL WAS RUN AND FOUND TO BE NEGATIVE. AFTER SEVERAL ATTEMPTS THIS INFORMATION WAS CONFIRMED ON A TELEPHONE CONVERSATION WITH LAB DIRECTOR (B)(6) ON 5/11/2016 WITH THE PRODUCT COMPLAINT SPECIALIST. (B)(6) ALSO STATED THAT THE BLOOD LEUKEMIA PANEL ORDER WAS BASED ON THE ENTIRE CLINICAL PICTURE OF THE PATIENT AND NOT JUST DUE TO THE ERRONEOUS PROMYELOCYTE COUNT PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    THE TECHNOLOGIST STATED THAT HE PERFORMED A MANUAL DIFFERENTIAL (MDIFF) IN WAM AND SOME OF THE KEYSTROKES WERE ENTERED INCORRECTLY. THE USER MISTAKENLY ENTERED 2 PROMYELOCYTES IN THE FIRST MDIFF COUNT AND SAVED THE RESULTS. THE USER WENT TO THE VALIDATION SCREEN AND A RULE FIRED THAT CALCULATED AN ABSOLUTE PROMYELOCYTE COUNT. THE TECHNOLOGIST REALIZED HIS ERROR AND WENT BACK TO THE MDIFF COUNT AND CHANGED THE PROMYELOCYTE COUNT TO 0. THE TECHNOLOGIST THEN PERFORMED A SECOND MDIFF COUNT IN WHICH 0 PROMYELOCYTES WERE ENTERED. THE USER EXPECTED RESULTS FROM THE SECOND MDIFF (COUNT 2) TO BE REPORTED HOWEVER, MDIFF RESULTS FROM THE FIRST COUNT WERE REPORTED TO A CLINICIAN. THE TECHNOLOGIST DID NOT FOLLOW THE APPROPRIATE PROCESS TO CORRECT THE RESULT BEFORE REPORTING. ONCE THE RULE TRIGGERS THE ONLY OPTION IS TO EDIT THE PROMYELOCYTE COUNT ON THE VALIDATION SCREEN BY CHANGING IT TO THE CORRECT RESULT (IN THIS CASE 0.0) OR ADD A FREE TEXT CODE SUCH AS "NOT MEASURED." THE USER INCORRECTLY MADE THE EDIT ON THE MANUAL DIFFERENTIAL SCREEN. THE RESULT COULD ALSO HAVE BEEN CORRECTED IF THE SECOND MDIFF COUNT HAD BEEN PERFORMED BEFORE THE USER RETURNED TO THE VALIDATION SCREEN AND THE RULE FIRED. THIS IS NORMAL WAM FUNCTION AND WAM PERFORMED AS DESIGNED. IT IS UNKNOWN IF OTHER CLINICAL SIGNS AND SYMPTOMS WARRANTED TREATMENT AND BONE MARROW BIOPSY. THE INCIDENT IS REPORTED BECAUSE THE PATIENT RECEIVED AN UNKNOWN TREATMENT AND A BONE MARROW BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251989 SYSMEX WORK AREA MANAGEMENT SYSTEM MIDDLEWARE OUG SYSMEX AMERICA INC. VERSION 5.0

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other