BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1083667 · Received July 22, 2008

    Report

    Report Number
    2954323-2008-02304
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    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. CUSTOMER REPORTED RECEIVING READINGS OF 16 MG/DL AND 151 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. IN ADDITION, CUSTOMER REPORTED EXPERIENCING SYMPTOM OF HEADACHE AND TOOK TYLENOL TO COUNTERACT HER SYMPTOM. NO THIRD PARTY MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT. NOTE: A BLOOD GLUCOSE READING BELOW 20 MG/DL WILL GIVE A REDING OF "LO" IN THE ADC METER.

    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 0728922

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK