BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1910224 · Received November 30, 2010

    Report

    Report Number
    2954323-2010-01618
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 30, 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 SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE METER IS DESIGNED TO DISPLAY READINGS OF 20 MG/DL TO 500 MG/DL. THIS METER DOES NOT SHOW A NUMERIC VALUE GREATER THAN 500 MG/DL NOR LESS THAN 20 MG/DL. A BLOOD GLUCOSE READING ABOVE 500 MG/DL WILL READ AS A "HI" IN THE ADC METER AND A BLOOD GLUCOSE READING BELOW 20 MG/DL WILL READ AS "LO".

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 501 MG/DL AND 19 MG/DL WERE PLOTTED ON THE PARKES ERROR GRID. THE RESULTS FELL INTO THE "D" 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

    Patients

    Seq Age Sex Outcome Treatment
    1