BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2173957 · Received July 24, 2011

    Report

    Report Number
    2954323-2011-03924
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 19, 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'S FAMILY MEMBER REPORTED THE TEST DOESN'T START AFTER SAMPLE IS APPLIED AND AS A RESULT OF BEING UNABLE TO TEST, THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS. THE PARAMEDICS WERE REPORTEDLY CALLED, BUT NO TREATMENT WAS PROVIDED. THE CUSTOMER SELF-TREATED WITH HUMALOG AND FOOD TO COUNTERACT THE EVENT. NO THIRD-PARTY MEDICAL INTERVENTION WAS REPORTED. 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 1155640

    Patients

    Seq Age Sex Outcome Treatment
    1 Other