BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1242583 · Received November 21, 2008

    Report

    Report Number
    2954323-2008-02901
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 21, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE DEVICE HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A CUSTOMER, WHO IS A RESIDENT OF A NURSING HOME, REPORTED RECEIVING A READING ON HIS FREESTYLE LIFE METER THAT WAS HIGHER THAN A READING OBTAINED ON A HEALTHCARE PRACTITIONER'S METER OF UNK BRAND (NO READINGS REPORTED BY CUSTOMER) AND SUBSEQUENTLY LOST CONSCIOUSNESS. CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH AN INTRAVENOUS INFUSION OF GLUCOSE AND GIVEN FOOD AND JUICE TO DRINK. THERE WAS NO REPORT DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0817217

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention