BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1133026 · Received August 20, 2008

    Report

    Report Number
    2954323-2008-02426
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 20, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED. THE CUSTOMER ALSO REPORTED NOT WASHING HANDS PRIOR TO TESTING AND ADC CUSTOMER SERVICE EDUCATED THE CUSTOMER TO WASH AND DRY HANDS BEFORE THE BLOOD GLUCOSE TEST.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A HIGH READING ON THEIR BLOOD GLUCOSE METER WHEN THEY EXPERIENCED SYMPTOMS OF LOW BLOOD GLUCOSE AND LOSS OF CONSCIOUSNESS. THE CUSTOMER REPORTED AN ADC METER READING OF 76 MG/DL. THE PARAMEDICS WERE CALLED AND ADMINISTERED AN INTRAVENOUS MEDICATION AND GLUCOSE. THE CUSTOMER REPORTED BEING TRANSPORTED TO THE FACILITY WHERE THEY WERE REPORTEDLY DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND TREATED WITH GLUCOSE. ADDITIONALLY, THE CUSTOMER REPORTED EATING FOOD TO ALLEVIATE THE SYMPTOMS. THERE WAS NO REPORT OF 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 0801103

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R