BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1623350 · Received March 5, 2010

    Report

    Report Number
    2954323-2010-00258
    Event Type
    Malfunction
    Date Received
    March 5, 2010
    Date of Event
    February 11, 2010
    Report Date
    March 5, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED METER ((B) (4)) WAS RETURNED, BUT NOT THE TEST STRIPS FROM LOT # 0918834. TESTS STRIPS FROM LOT # 0915618 WERE RETURNED INSTEAD. THE COMPLAINT WAS NOT CONFIRMED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. THE REPORTED READINGS WERE FOUND IN THE METER MEMORY LOG WITHIN A TEN MINUTE TIMEFRAME (DATE: (B) (6) 2010). THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED SHE RECEIVED THE FOLLOWING READINGS ON HER BLOOD GLUCOSE METER WITHIN 10 MINUTES: 41 MG/DL, 170 MG/DL, 439 MG/DL, 160 MG/DL AND 173 MG/DL. RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND 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 0918834

    Patients

    Seq Age Sex Outcome Treatment
    1