BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7

    MDR report key: 22497748 · Received July 14, 2025

    Report

    Report Number
    MW5172593
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    July 9, 2025
    Report Date
    July 9, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON DAY 1 OF USING A DEXCOM G7 SENSOR, THE DEVICE REPORTED 170 MG/DL WHEN A FINGERSTICK METER READ 73 MG/DL. THIS 100-POINT DISCREPANCY IS COMMON IN MY EXPERIENCE WITH EVERY G7 SENSOR I'VE USED, AND IT CREATES DANGEROUS CONDITIONS FOR INSULIN DOSING AND OVERNIGHT SAFETY. DEXCOM PROVIDES NO OPTION FOR ACCURATE CALIBRATION OR CORRECTION. I RELY ON THIS SYSTEM TO MANAGE TYPE 1 DIABETES, AND THIS LEVEL OF INACCURACY PUTS MY LIFE AT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647132 DEXCOM G7 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC. 1725112005

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Other| R| L INSULIN (RAPID AND LONG ACTING).| LEVOTHYROXINE.