BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 2123081 · Received June 14, 2011

    Report

    Report Number
    2954323-2011-03549
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 26, 2011
    Report Date
    August 2, 2011
    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. NOTE: THE CUSTOMER REPORTED RECEIVING A "HI" ON THEIR METER DISPLAY. THE REPORTED METER IS DESIGNED TO DISPLAY READINGS OF 20 MG/DL TO 500 MG/DL AND DOES NOT SHOW A NUMERIC VALUE GREATER THAN 500 MG/DL OR LESS THAN 20 MG/DL. A BLOOD GLUCOSE READING ABOVE 500 MG/DL WILL READ AS A "HI" IN THE ADC METER AND A BLOOD GLUCOSE READING BELOW 20 MG/DL WILL READ AS "LO" IN THE ADC METER.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READINGS THE CUSTOMER REPORTED WERE NOT FOUND IN THE METER MEMORY WITHIN 10 MINUTES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 19 MG/DL, 501 MG/DL, AND 158 MG/DL WERE PLOTTED ON THE PARKES ERROR GRID. THE RESULTS 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 BLOOD GLUCOSE MONITORING SYSTEM NBW 0931722

    Patients

    Seq Age Sex Outcome Treatment
    1