BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2230204 · Received September 1, 2011

    Report

    Report Number
    2954323-2011-04341
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 31, 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 OBTAINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR 3 MESSAGE ON HIS ADC BLOOD GLUCOSE METER AND DOES NOT START AFTER THE SAMPLE APPLIED. CUSTOMER FURTHER REPORTED SUBSEQUENTLY "WOKE UP ON THE FLOOR" AND EXPERIENCING SHAKINESS, SEIZURE, AND LOST CONSCIOUSNESS. NO THIRD-PARTY MEDICAL INTERVENTION WAS REPORTED. CUSTOMER SELF-TREATED BY DRINKING A CAN OF SODA AND EATING CUPCAKES. 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1166805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other