BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 1820901 · Received September 14, 2007

    Report

    Report Number
    2954323-2007-17317
    Event Type
    Injury
    Date Received
    September 14, 2007
    Date of Event
    August 16, 2007
    Report Date
    September 14, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    FMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR FREESTYLE LANCING DEVICE WOULD NOT FIRE, AND CONSEQUENTLY COULD NOT OBTAIN A BLOOD GLUCOSE RESULT PROPERLY. CUSTOMER REPORTED USING THE LANCING DEVICE WITH A BD LOGIC BRAND OF GLUCOSE MONITOR. CUSTOMER THEN REPORTED SYMPTOMS OF THIRST, VOMITING, AND DECREASED BODY TEMPERATURE. CUSTOMER'S DAUGHTER CALLED THEIR HEALTH CARE PROVIDER, AND WAS INSTRUCTED TO BRING HER MOTHER TO THE HEALTH CARE FACILITY. CUSTOMER WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. EXACT TREATMENT ADMINISTERED IN ORDER TO STABILIZE GLUCOSE LEVELS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LANCING DEVICE FMK ABBOTT DIABETES CARE INC., USA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention