BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1020028 · Received March 27, 2008

    Report

    Report Number
    2954323-2008-01213
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 27, 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 REPORTED RECEIVING ERRATIC GLUCOSE READINGS FROM THEIR FREESTYLE FREEDOM METER. CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF HEADACHE, SHORTNESS OF BREATH, TIREDNESS, SLEEPINESS AND EXCESS URINATION. CUSTOMER ALSO REPORTED GOING TO A LOCAL HOSPITAL WHERE SHE WAS TREATED WITH AN INSULIN SHOT AND PAIN MEDICATION. THE DIAGNOSIS AT THE HOSPITAL IS UNKNOWN, AN INVESTIGATION INTO THE DETAILS OF THIS EVENT IS IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NA 0733141

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R