BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENLITE SENSOR

    MDR report key: 6349243 · Received February 17, 2017

    Report

    Report Number
    MW5068012
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    February 17, 2017
    Report Date
    February 17, 2017
    Manufacturer
    MEDTRONIC INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC INC'S ENLITE CONTINUOUS GLUCOSE MONITORS ARE FAILING CONSTANTLY AND RARELY MEET THE RECOMMENDED USE PERIOD. THE RECOMMENDED PERIOD OF TIME IS 6 DAYS BUT ARE RARELY GOOD FOR MORE THAN 4 DAYS. BEFORE THE SENSORS COMPLETELY GO OUT THEY CAN GIVE UP TO 12 HOURS OF INACCURATE DATE POSSIBLY LEADING TO DIABETICS TREATING FOR THESE FALSE NUMBERS LEADING TO LONG TERM DAMAGE OR ENTERING A DIABETIC COMA. THESE PROBLEMS RANGE FROM DIFFERENT LOTS AND BATCHES. THIS IS AN ENORMOUS PROBLEM ESPECIALLY WITH THE NEW PRODUCTS MEDTRONIC IS PUTTING OUT BECAUSE IF A CLOSED LOOP INSULIN PUMP USES THESE INACCURATE NUMBERS, IT COULD LEAD TO THE DEATH OF A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124063 ENLITE SENSOR GLUCOSE SENSOR MDS MEDTRONIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening| R MEDTRONIC INC., 630G INSULIN PUMP| MEDTRONIC INC., GUARDIAN CONTINUOUS GLUCOSE-| NOVALOG| TRANSMITTER