BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX

    MDR report key: 5506789 · Received March 15, 2016

    Report

    Report Number
    MW5060931
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Report Date
    February 15, 2016
    Manufacturer
    SYSMEX AMERICA, INC.
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON THE SYSMEX XS HEMATOLOGY ANALYZER, DURING NORMAL OPERATION IN MANUAL MODE, IF THE OPERATOR DOES NOT INPUT A SPECIMEN IDENTIFICATION NUMBER, THE SOFTWARE AUTOMATICALLY ASSIGNS THE NEXT SEQUENTIAL SPECIMEN ID NUMBER. THE NEXT SPECIMEN ID NUMBER BELONGS TO A DIFFERENT SPECIMEN AND PATIENT. FOUR INCIDENTS OF INCORRECT PATIENT RESULTS BEING FILLED IN THE WRONG RECORDS WERE TRACED, DURING ROOT CAUSE INVESTIGATIONS, TO THIS SOFTWARE DESIGN FLAW. FIRST EVENT OCCURRED IN (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156633 SYSMEX HEMATOLOLGY ANALYZER GKZ SYSMEX AMERICA, INC. XS-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other