BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX XN-10

    MDR report key: 4168819 · Received September 22, 2014

    Report

    Report Number
    4168819
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 22, 2014
    Manufacturer
    SYSMEX AMERICA INC.
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    ABOUT A WEEK AGO, WE BECAME AWARE OF FAILURE OF OUR TWO SYSMEX XN-10 INSTRUMENTS TO FLAG PERIPHERAL BLOOD CBC SPECIMENS FOR CLUMPED PLATELETS. FAILURE TO FLAG FOR CLUMPED PLATELETS RESULTED IN RELEASE OF FALSELY LOW PLATELET COUNTS. THIS FLAGGING ISSUE APPEARS TO BE SPORADIC AND WAS REPORTED IMMEDIATELY TO SYSMEX. DUE TO DELAYED RESPONSE FROM SYSMEX TECHNICAL SUPPORT, ONE OF THE SYSMEX REGULATORY INVESTIGATORS WAS CONTACTED A COUPLE OF DAYS LATER. THE REGULATORY INVESTIGATOR INFORMED US THAT SYSMEX HAS BEEN AWARE OF THIS ISSUE SINCE THIS SUMMER. WE EXPRESSED OUR CONCERNS THAT NO PROACTIVE NOTIFICATION OR CORRECTIVE ACTION HAS BEEN PROVIDED BY SYSMEX TO END USERS OF THE SYSMEX XN-10. AT THIS TIME WE WERE TOLD THAT THEY ARE COLLECTING DATA AND THAT THERE IS NO FORMAL RESOLUTION TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588113 SYSMEX XN-10 COUNTER, DIFFERENTIAL CELL GKZ SYSMEX AMERICA INC. SYSMEX XN-10 *
    588114 SYSMEX XN-10 COUNTER, DIFFERENTIAL CELL GKZ SYSMEX AMERICA INC. SYSMEX XN-10 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *