BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1651994 · Received April 6, 2010

    Report

    Report Number
    2954323-2010-00431
    Event Type
    Malfunction
    Date Received
    April 6, 2010
    Date of Event
    March 10, 2010
    Report Date
    April 6, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER (B) (4) WAS RETURNED AND TESTED WITH RETURNED TEST STRIPS LOT # 0934116. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION. ADDITIONALLY, THE REPORTED COMPARISON VALUE OF 125 MG/DL WAS FOUND IN THE DEVICE'S INTERNAL MEMORY LOG.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING INACCURATE READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING A READING OF 125 MG/DL COMPARED TO A LAB READING OF 66 MG/DL WITHIN 10 MINUTES. 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 0934116

    Patients

    Seq Age Sex Outcome Treatment
    1