BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1010179 · Received March 10, 2008

    Report

    Report Number
    2954323-2007-22442
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    October 18, 2007
    Report Date
    November 16, 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 FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED.

    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. THE CUSTOMER REPORTED MAKING CHANGES TO THEIR DIABETES TREATMENT BASED ON THESE RESULTS, AND EXPERIENCING A HEADACHE. HOWEVER, THERE WAS NO REPORT OF DEATH, 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 0716629

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK