BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2160859 · Received July 13, 2011

    Report

    Report Number
    2954323-2011-03843
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 18, 2011
    Report Date
    July 11, 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 AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011 A CUSTOMER REPORTED THE TEST WOULD NOT START AFTER A SAMPLE WAS APPLIED USING HER FREESTYLE FREEDOM LITE METER. THE CUSTOMER STATED "A WEEK AND A HALF AGO" (SHE WAS UNABLE TO RECALL THE EXACT DATE), SHE WAS UNABLE TO OBTAIN A READING ON HER METER. THE CUSTOMER STATED SHE CONTACTED HER DOCTOR AND WAS TOLD TO CONTACT ABBOTT. THE CUSTOMER REPORTED SYMPTOMS SHE DESCRIBED AS "EXTREMELY LOW BLOOD SUGAR COULDN'T GET UP AND FUNCTION." THE CUSTOMER ALSO REPORTED A LOSS OF CONSCIOUSNESS, ALTHOUGH SHE DENIED RECEIVING ANY MEDICAL TREATMENT. THE CUSTOMER REPORTED SELF-TREATMENT WITH "A SHOT OF GLUCAGON", AND "PUT SUGAR UNDER HER TONGUE." THERE IS 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 1107301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other