BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1355911 · Received March 20, 2009

    Report

    Report Number
    1355911
    Event Type
    Malfunction
    Date Received
    March 20, 2009
    Date of Event
    March 11, 2009
    Report Date
    March 20, 2009
    Manufacturer
    SYSMEX AMERICA, INC.
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    THE MACHINE HAD A TEMPERATURE ERROR. THE TEMPERATURE WAS RESET BY TURNING THE MACHINE OFF AND ON. ULTIMATELY, THE ENTIRE RED CELL BLOCK WAS REPLACED BY SYSMEX. ERRONEOUS RESULTS WERE REPORTED ON SEVERAL PATIENTS. ONLY ONE IS LISTED IN THIS REPORT SINCE IT INVOLVED THE SAME PIECE OF EQUIPMENT. NO PATIENT HARM HAS COME FROM THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR