BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE XL

    MDR report key: 14161664 · Received April 19, 2022

    Report

    Report Number
    MW5109179
    Event Type
    Injury
    Date Received
    April 19, 2022
    Date of Event
    April 16, 2022
    Report Date
    April 16, 2022
    Manufacturer
    ASCENSIA/SENSEONICS / SENSEONICS, INC.
    Product Code
    QCD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    EVERSENSE CGM NOT ACCURATE; EIGHTY TWO DAYS AGO I SWITCHED FROM THE DEXCOM G6 CGM TO THE EVERSENSE XL. THE UNIT CONSTANTLY REPORTS LOW SUGAR WHEN IT IS NOT LOW. IT NEEDS TO BE CALIBRATED CONSTANTLY AT ALL HOURS OF THE DAY AND NIGHT. IF YOU MISS A CALIBRATION, THEN YOU NEED TO RE-CALIBRATE 4 TIMES OVER 8 HOURS. TRANSMITTER DISCONNECTS ALL THE TIME. THIS ITEM WAS DESIGNED TO BE BROKEN AND I THINK THE VENDOR KNEW THAT. AND FINALLY THE APP SAYS TO NEVER USE THE EVERSENSE TO MAKE MEDICAL DECISIONS LIKE WHEN NEEDING INSULIN. IF THAT IS THE CASE, WHAT IS THE USE OF HAVING THIS EXPENSIVE DEVICE. THE BOTTOM LINE IS, THE EVERSENSE IS JUST PRODUCED TO MAKE MONEY AND DOES NOT HELP AT ALL WITH DIABETES MANAGEMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625871 EVERSENSE XL CONTINUOUS GLUCOSE MONITOR, IMPLANTED, ADJUNCTIVE USE QCD ASCENSIA/SENSEONICS / SENSEONICS, INC. EVERSENSE XL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other AMOXI-CLAV 875-125 MG | CLOPIDGREL 75 MG ONCE PER DAY AM | COATED ASPIRIN 81 MG TAB ONCE PER DAY AM | DULOXETINE 30 MG ONCE PER DAY AM | FENOFIBRATE 48MG TAB 2 X 48MG ONCE PER DAY AM| FIASP 60 UNITS SLIDING MEALS 3X TO 4X A DAY| HYDROCHLOROTHIAZIDE TAB 25MG 1/DAY AM | JARDIANCE 25MG ONCE PER DAY AM | LOSARTAN 100MG ONCE PER DAY AM | METOPROLOL 50MG ONCE PER DAY PM | OMEGA-3 ETHEL ESTERS 1GM 2GM AM 2GM PM| REPATHA INJECTION 140MG EVERY TWO WEEKS | TRESIBA U-200 150 UNITS AM | TWICE PER DAY AM-PM | VITAMIN D3 2000 IU 1/DAY AM