BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1040449 · Received May 8, 2008

    Report

    Report Number
    2954323-2008-01751
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 20, 2008
    Report Date
    May 8, 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. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A NUMBER OF READINGS ON THEIR FREESTYLE LITE BLOOD GLUCOSE MONITOR WHICH WERE REPORTED TO BE HIGHER THAN HOW THEY WERE FEELING. THE TIMEFRAME IN WHICH THESE READINGS WERE OBTAINED IS UNK. THE CUSTOMER THEN REPORTED FEELING SWEATY AND EXPERIENCING A LOSS OF CONSCIOUSNESS. THEY WERE TRANSPORTED TO A LOCAL EMERGENCY ROOM, WHERE SHE WAS DIAGNOSED WITH HYPOGLYCEMIA. THE CUSTOMER REPORTED THAT GLUCOSE WAS ADMINISTERED IN ORDER TO STABILIZE GLUCOSE LEVELS. 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 NA 0728442

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R