BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 MOBILE APP

    MDR report key: 17135629 · Received June 14, 2023

    Report

    Report Number
    MW5118400
    Event Type
    Injury
    Date Received
    June 14, 2023
    Date of Event
    June 12, 2023
    Report Date
    June 12, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    PJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TODAY I FELL ASLEEP FROM SIDE EFFECTS OF A HIGH BLOOD SUGAR CAUSED BY MY DEXCOM G7 RECEIVER NOT ALARMING ME OF INCREASING BLOOD SUGAR. THE DEXCOM G7 RECEIVER ALARMS ONLY ONE TIME WHEN PRESET THRESHOLDS OF HIGH OR LOW BLOOD GLUCOSE LEVELS ARE REACHED AND DO NOT REPEAT. THE G7 APP FOR IPHONE IS USELESS AS IT ALMOST ALWAYS LOSES CONNECTION TO THE G7 SENSOR/TRANSMITTER. MY DIABETES CONTROL AND LIFE IS BEING AFFECTED BY THIS DEVICE. I HAVE REACHED OUT MULTIPLE TIMES TO DEXCOM TECH SUPPORT AND THEY HAVE REPLACED THE RECEIVER WHICH HASN'T CORRECTED THIS ISSUE. REFERENCE REPORT: MW5118399.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057298 DEXCOM G7 MOBILE APP CONTINUOUS GLUCOSE MONITOR SECONDARY DISPLAY PJT DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Life Threatening MULTIVITAMIN.| NOVALOG, AFREZZA, TOUJEO.