BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2032947 · Received March 29, 2011

    Report

    Report Number
    2954323-2011-02703
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 29, 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 CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. IT SHOULD BE NOTED: THE DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE TEST DID NOT START AFTER A SAMPLE WAS APPLIED TO A TEST STRIP INSERTED INTO HER FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER. SHE FURTHER REPORTED SUBSEQUENTLY EXPERIENCING VERTIGO. IT IS UNKNOWN IF THE CUSTOMER ATTEMPTED TO SELF-TREAT OR IF SHE RECEIVED THIRD-PARTY MEDICAL INTERVENTION BECAUSE THE CUSTOMER DECLINED TO FINISH TROUBLESHOOTING. HOWEVER, CUSTOMER INDICATED SHE HAD SUSTAINED AN INJURY BECAUSE, "MY SUGAR WAS UP AND I WAS VERY DIZZY". PRIOR TO DISCONNECTING THE CALL, IT WAS DISCOVERED THE CUSTOMER WAS NOT USING PROPER TECHNIQUE AND SHE WAS ATTEMPTING TO TEST FROM THE METER'S MEMORY. 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 FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0927718

    Patients

    Seq Age Sex Outcome Treatment
    1 Other