BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1970686 · Received January 25, 2011

    Report

    Report Number
    2954323-2011-00963
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 25, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE METER HAS NOT BEEN WORKING FOR A WHILE AND ABOUT 4 MONTHS AGO THEY HAD AN EPISODE OF LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED AND REPORTEDLY ADMINISTERED AN INJECTION TO BRING THEIR SUGAR UP. THE CUSTOMER WAS TRANSPORTED TO THE HOSPITAL AND TREATED FOR SEVERE HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0920944

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R