BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2160329 · Received July 13, 2011

    Report

    Report Number
    2954323-2011-03838
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 21, 2011
    Report Date
    August 18, 2011
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. A SIMILAR READING TO THE READING THE CUSTOMER REPORTED WAS FOUND IN THE METER MEMORY.

    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

    A CUSTOMER REPORTED RECEIVING INACCURATE READINGS ON THEIR ADC BLOOD GLUCOSE MONITOR. THE CUSTOMER REPORTED COMPARING AN ADC METER READING OF 138 MG/DL TO A LAB RESULT OF 58 MG/DL. THE BLOOD TESTS WERE REPORTEDLY PERFORMED WITHIN TEN MINUTES. THE RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "C" ZONE SHOWING THE DIFFERENCES IN VALUES WAS 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 1013723

    Patients

    Seq Age Sex Outcome Treatment
    1