BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 2001154 · Received February 24, 2011

    Report

    Report Number
    2954323-2011-01730
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 5, 2011
    Report Date
    February 24, 2011
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HE RECEIVED ON (B)(6) 2011 WITHIN TEN MINUTES THE FOLLOWING ERRATIC READINGS ON HIS FREESTYLE LITE BLOOD GLUCOSE METER: 419 MG/DL AND 119 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. ALTHOUGH THE CUSTOMER ALSO REPORTED HE EXPERIENCED SYMPTOMS OF FATIGUE AND DRY MOUTH, THOSE SYMPTOMS REPORTEDLY OCCURRED ON (B)(6) 2011. THEREFORE THERE IS NO INDICATION THAT AN ADC PRODUCT CONTRIBUTED TO THE CUSTOMER'S SYMPTOMS AS THEY OCCURRED PRIOR TO THE REPORTED READINGS. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1008440

    Patients

    Seq Age Sex Outcome Treatment
    1