BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2182383 · Received July 28, 2011

    Report

    Report Number
    2954323-2011-04020
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 27, 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 AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER'S DAUGHTER REPORTED CUSTOMER'S FREESTYLE LITE BLOOD GLUCOSE METER WOULD TURN ON AND THEN OFF AFTER A TEST STRIP WAS INSERTED INTO IT. CALLER FURTHER REPORTED THAT APPROXIMATELY TWO WEEKS PRIOR TO CALLING ON (B)(6), 2011 CUSTOMER WAS UNABLE TO TEST DUE TO THE METER TURNING OFF AND SUBSEQUENTLY EXPERIENCED LIGHTHEADEDNESS AND VERTIGO, WHICH RESULTED IN A SEIZURE. PARAMEDICS WERE CALLED, ADMINISTERED GLUCOSE VIA INTRAVENOUS INFUSION AND TRANSPORTED CUSTOMER TO A LOCAL HEALTHCARE FACILITY WHERE SHE WAS DIAGNOSED WITH HYPOGLYCEMIA. CALLER WAS UNABLE TO REPORT WHAT ADDITIONAL TREATMENT MAY HAVE BEEN RENDERED AT THE HOSPITAL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1073110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R