BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2924326 · Received January 22, 2013

    Report

    Report Number
    2954323-2013-00037
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. THE ACTUAL DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN. THE DATE LISTED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT APPROXIMATELY TWO WEEKS PRIOR TO CALLING CUSTOMER SERVICE ON (B)(6) 2012 SHE AWOKE FROM SLEEP EXPERIENCING "SHAKINESS" AND WAS "SWEATY", BUT WHEN SHE ATTEMPTED TO TEST USING HER ADC BLOOD GLUCOSE METER SHE NOTICED A BATTERY ICON ON THE DISPLAY. CUSTOMER FURTHER REPORTED SUBSEQUENTLY EXPERIENCING A LOSS OF CONSCIOUSNESS. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER SELF-TREATED BY PLACING A COLD TOWEL ON HER HEAD AND EATING A PEPPERMINT CANDY. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30757 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1164458

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other