BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2973020 · Received February 21, 2013

    Report

    Report Number
    2954323-2013-00118
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETAINED TEST STRIPS. 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. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY. GIVEN NO TEST STRIPS WERE RETURNED FOR INVESTIGATION, RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1274425) WERE TESTED WITH CONTROL SOLUTION. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING INACCURATE READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED COMPARING AN ADC METER READING OF 133 MG/DL TO A LAB RESULT OF 511 MG/DL. THE BLOOD TESTS WERE REPORTEDLY PERFORMED WITHIN TEN MINUTES. THE RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND FELL IN THE "D" ZONE SHOWING THE DIFFERENCE 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
    76977 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1274425

    Patients

    Seq Age Sex Outcome Treatment
    1