BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX XE-2100

    MDR report key: 1623355 · Received February 23, 2010

    Report

    Report Number
    1623355
    Event Type
    Malfunction
    Date Received
    February 23, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 23, 2010
    Manufacturer
    SYSMEX AMERICA, INC
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CBC (COMPLETE BLOOD COUNT) PRINTOUT FROM SYSMEX XE-2100 HEMATOLOGY ANALYZER HAD PATIENT DEMOGRAPHICS FOR ONE PATIENT, BUT HAD A DIFFERENT PATIENT'S RESULTS. SYSMEX WAS CONTACTED. ALL PERTAINING DOCUMENTS HAVE BEEN COPIED AND FORWARDED TO SYSMEX. SYSMEX DID NOT HAVE AN EXPLANATION AND STATED AN INVESTIGATION WOULD BE OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX XE-2100 HEMATOLOGY ANALYZER GKZ SYSMEX AMERICA, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *