BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1192040 · Received October 7, 2008

    Report

    Report Number
    2954323-2008-02683
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A LOW GLUCOSE READING (98MG/DL) FROM THEIR FREESTYLE LITE METER. CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA AND WEAKNESS. PARAMEDICS WERE CALLED AND TREATED CUSTOMER WITH GLUCOSE AND TRANSPORTED CUSTOMER TO FALMOUTH HOSPITAL WHERE SHE WAS BEING TREATED WITH INTRAVENOUS SOLUTION. THERE WAS NO REPORT OF DIAGNOSIS, 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 NA 0801119

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization