BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1843101 · Received September 23, 2010

    Report

    Report Number
    2954323-2010-01324
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 23, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: A BLOOD GLUCOSE READING ABOVE 500 MG/DL WILL GIVE A READING OF "HI" IN THE ADC METER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE FREEDOM LITE METER. CUSTOMER REPORTED RECEIVING READINGS OF 501 MG/DL, 185 MG/DL, 125 MG/DL, 464 MG/DL, 225 MG/DL, 98 MG/DL AND 93 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. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1005737

    Patients

    Seq Age Sex Outcome Treatment
    1