BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1811730 · Received August 23, 2010

    Report

    Report Number
    2954323-2010-01151
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 23, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER HAS BEEN RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2010 CUSTOMER REPORTED RECEIVING A READING OF 189 MG/DL ON THEIR FREESTYLE FREEDOM LITE GLUCOSE METER THAT WAS HIGHER THAN THE LAB RESULT OF 69 MG/DL OBTAINED WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "D" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1008735

    Patients

    Seq Age Sex Outcome Treatment
    1