BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1000070 · Received February 15, 2008

    Report

    Report Number
    2954323-2008-00824
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 14, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. 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'S MOTHER REPORTED NOT BEING ABLE TO TEST CUSTOMER'S BLOOD GLUCOSE DUE TO BLANK SCREEN THAT APPEARS ON THEIR FREESTYLE FLASH METER. AS A RESULT, THE CUSTOMER WENT TO CONSULT THEIR DOCTOR. CUSTOMER'S MOTHER REPORTED CUSTOMER EXPERIENCED SYMPTOMS OF "UPPER BODY SHAKINESS, LEFT HAND TREMBLES, FATIGUE AND DIABETIC SEIZURE" DURING THEIR DOCTOR'S APPOINTMENT. CUSTOMER'S MOTHER REPORTED CUSTOMER WAS TREATED WITH FIVE TABLETS TO TREAT LOW SUGAR SYMPTOMS. THERE IS NO REPORT ON DIAGNOSIS FROM THE DOCTOR.

    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 0717816

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention