BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 952536 · Received April 25, 2007

    Report

    Report Number
    2954323-2007-05847
    Event Type
    Malfunction
    Date Received
    April 25, 2007
    Date of Event
    March 26, 2007
    Report Date
    April 25, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A F/U REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE LETTER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE UNIT OF MEASUREMENT SETTING OF THEIR FREESTYLE FLASH BLOOD GLUCOSE MONITOR CHANGED FROM MMOL/L TO MG/DL. CUSTOMER REPORTED DOSING WITH INSULIN BASED ON READINGS OBTAINED IN THE INCORRECT UNIT OF MEASUREMENT, AND THEN FEELING LIGHTHEADED. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC., USA NA 0624903

    Patients

    Seq Age Sex Outcome Treatment
    1 YR