BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1557666 · Received December 11, 2009

    Report

    Report Number
    2954323-2009-02144
    Event Type
    Malfunction
    Date Received
    December 11, 2009
    Date of Event
    November 20, 2009
    Report Date
    January 22, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER (B) (4) AND REPORTED STRIP LOT # 0922536 WAS RETURNED FOR INVESTIGATION. 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 READINGS THE CUSTOMER REPORTED WERE FOUND IN METER'S MEMORY ON THE DAY OF THE REPORTED EVENT.

    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. NOTE: THE METER IS DESIGNED TO DISPLAY READINGS OF 20 MG/DL TO 500 MG/DL. THIS METER DOES NOT SHOW A NUMERIC VALUE GREATER THAN 500 MG/DL. A BLOOD GLUCOSE READING ABOVE 500 MG/DL WILL READ AS A "HI" IN THE ADC METER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM IS INTERMITTENTLY DISPLAYING A POTENTIOMETER ERROR. NO PT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 124 MG/DL, "HI" (GREATER THAN 500 MG/DL) AND 122 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" ZONES 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 0922536

    Patients

    Seq Age Sex Outcome Treatment
    1