BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 940908 · Received April 19, 2007

    Report

    Report Number
    2954323-2007-05400
    Event Type
    Malfunction
    Date Received
    April 19, 2007
    Date of Event
    March 20, 2007
    Report Date
    April 19, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE UNIT OF MEASURE SETTING OF THEIR FREESTYLE METER CHANGED FROM MMOL/L TO MG/DL AND THEY WERE ALSO RECEIVING AN ERROR 4 MESSAGE AND BATTERY/BOOKLET ICON WHICH IS THE INDICATION THAT METER MAY HAVE EXHIBITED A MEMORY OVERWRITE MALFUNCTION. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC., USA NI 053170

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO