BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1000961 · Received February 5, 2008

    Report

    Report Number
    2954323-2008-00725
    Event Type
    Injury
    Date Received
    February 5, 2008
    Date of Event
    December 23, 2007
    Report Date
    February 6, 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

    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 ERRATIC READINGS ON THEIR FREESTYLE LITE BLOOD GLUCOSE MONITOR. THE CUSTOMER REPORTED MAKING CHANGES TO THEIR INSULIN MEDICATION BASED ON THE RECEIVED READINGS, AND THEN REPORTED FEELING SHAKY, SWEATY, AND BEGAN TO VOMIT, AND THEN REPORTED EXPERIENCING A LOSS OF CONSCIOUSNESS. HE WAS TRANSPORTED TO A LOCAL HOSPITAL, WHEN HE WAS DIAGNOSED WITH HYPOGLYCEMIA. D50 (DEXTROSE) WAS ADMINISTERED IN ORDER TO STABILIZE GLUCOSE LEVELS. IN ADDITION, THE CUSTOMER ALSO REPORTED RECEIVING READINGS OF 89 MG/DL AND 169 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "B" ZONE SHOWING THE DIFFERENCE IN VALUES TO NOT BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH OF 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 0713130

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R