BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1799766 · Received August 13, 2010

    Report

    Report Number
    2954323-2010-01122
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 25, 2010
    Report Date
    August 13, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER (B)(4) WAS RETURNED AND TESTED WITH RETAINED TEST STRIPS LOT # 1002834. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION. ADDITIONALLY, SIMILAR READINGS OF 139 MG/DL, 464 MG/DL, AND 297 MG/DL WERE FOUND IN THE DEVICE'S INTERNAL MEMORY LOG WITHIN 10 MINUTES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 370 MG/DL, 476 MG/DL, AND 139 MG/DL WITHIN 10 MINUTES. 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 1004715

    Patients

    Seq Age Sex Outcome Treatment
    1