BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2080736 · Received May 6, 2011

    Report

    Report Number
    2954323-2011-03208
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 6, 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 REPORTED SHE RECEIVED AN ERROR 3 MESSAGE ON HER FREESTYLE FREEDOM LITE METER UPON SAMPLE APPLICATION. DUE TO THE ERROR MESSAGE, THE CUSTOMER STATED SHE WAS UNABLE TO TEST. ON (B)(6) 2011 AT 8PM THE CUSTOMER WAS AT HER SON'S HOUSE AND REPORTED "SHE COULD NOT READ A WORD IN THE BOOK SHE WAS READING. SHE WAS TIRED AND COULD NOT SEE. SHE WAS UNABLE TO TEST AND BECAME UNCONSCIOUS." THE CUSTOMER REPORTED WHEN SHE WOKE UP AT 11:30PM SHE WAS "FOAMING AT THE MOUTH, SWEATING PROFUSELY, AND GRINDING HER TEETH." SHE DESCRIBED HER SYMPTOMS AS BOTH A SEIZURE AND LOSS OF CONSCIOUSNESS. THE CUSTOMER SELF-TREATED BY EATING A MEAL AND DRINKING WATER. NO EMERGENT THIRD-PARTY INTERVENTION WAS REQUIRED. THERE WAS NO REPORT OF PERMANENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1036120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other