BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1832142 · Received September 13, 2010

    Report

    Report Number
    2954323-2010-01258
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 20, 2010
    Report Date
    September 10, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. NOTE: CUSTOMER REPORTED NOT KNOWING IF THE REPORTED READINGS WERE OBTAINED WITHIN 10 MINUTES, OR IF THEY ATE BETWEEN READINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 71 MG/DL, 400 MG/DL, 26 MG/DL, 366 MG/DL, 66 MG/DL, 435 MG/DL, AND 129 MG/DL. 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 0931912

    Patients

    Seq Age Sex Outcome Treatment
    1