BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1962981 · Received January 18, 2011

    Report

    Report Number
    2954323-2011-00703
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 18, 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. NOTE: THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THEIR METER TURNS ON WITH BUTTON, BUT NOT WITH TEST STRIP AND AS A RESULT OF BEING UNABLE TO TEST, THEY EXPERIENCED VERTIGO, TIREDNESS AND REPORTEDLY LOST CONSCIOUSNESS AND SELF-TREATED BY DRINKING JUICE 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other