BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1000029 · Received February 13, 2008

    Report

    Report Number
    2954323-2008-00804
    Event Type
    Injury
    Date Received
    February 13, 2008
    Date of Event
    January 12, 2008
    Report Date
    February 13, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED METER. THE COMPLAINT IS UNDER INVESTIGATION AND A FOLLOW-UP REPORT WILL BE FILED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A READING OF 329 MG/DL ON HER FREESTYLE FREEDOM BLOOD GLUCOSE METER, TOOK INSULIN BASED ON THAT READING AND THEN LOST CONSCIOUSNESS. AFTER WAKING UP, SHE PERFORMED ANOTHER BLOOD GLUCOSE TEST AND THE READING WAS 255 MG/L . THE PARAMEDICS WERE CALLED, TESTED HER BLOOD GLUCOSE AND THE READING OBTAINED WAS 45 MG/DL. THE CUSTOMER REPORTED THE PARAMEDICS GAVE HER GLUCOSE AND DID NOT TAKE HER TO THE HOSPITAL. SHE ALSO REPORTED DRINKING ORANGE JUICE AND HAVING PEANUT BUTTER AND BREAD TO COUNTERACT THE SYMPTOMS. 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 BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. NA 0727717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Required Intervention