BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1152847 · Received September 5, 2008

    Report

    Report Number
    2954323-2008-02496
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 3, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED.

    Description of Event or Problem · 1

    THE MOTHER REPORTED, HER SON HAD DIFFICULTY IN BREATHING AND TOOK HIM TO A HOSPITAL WHERE HE WAS REPORTEDLY DIAGNOSED WITH DKA (DIABETIC KETOACIDOSIS), AND TREATED WITH INSULIN AND INTRAVENOUS FLUIDS. THE MOTHER ALSO REPORTED OBTAINING AN ADC METER READING OF 102 MG/DL AND COMPARING TO THE HEALTH CARE METER READING OF 352 MG/DL. ADDITIONALLY, THE MOTHER REPORTED THE METER WAS NOT RETAINING THE CORRECT DATE AND TIME. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0816919

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R