BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1630096 · Received March 12, 2010

    Report

    Report Number
    2954323-2010-00305
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    February 16, 2010
    Report Date
    March 12, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE DEVICE (B) (4) AND TEST STRIPS (LOT NO: 0925426) HAVE BEEN RETURNED AND AN INVESTIGATION UTILIZING THE RETURNED METER, RETURNED TEST STRIPS AND RETAINED CONTROL SOLUTIONS (LOTS NO: 9F1P11 AND 9F3P11) HAS DETERMINED THE COMPLAINT IS NOT CONFIRMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. A REVIEW OF THE METER'S INTERNAL MEMORY LOG REVEALED THE REPORTED READINGS. HOWEVER, THEY WERE RECEIVED ON (B) (6) 2010.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HER FREESTYLE LITE BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 418 MG/DL AND 110 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" 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0925426

    Patients

    Seq Age Sex Outcome Treatment
    1