BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22784987 · Received August 12, 2025

    Report

    Report Number
    3004753838-2025-219235
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    July 27, 2025
    Report Date
    August 12, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270003935
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE SENSOR STOPPED WORKING (FAILED) IN THE MIDDLE OF THE NIGHT WHILE THE PATIENT WAS ASLEEP. IT WAS REPORTED THAT DUE TO THIS ISSUE, THE PUMP STOPPED GIVING INSULIN. WHEN THE PATIENT WOKE UP VOMITING. THEY CHECKED A FINGER STICK READING AND IT WAS 500 MG/DL AND HAD KETONES. THE PATIENT STATED EHY HAD TO DOUBLE INSULING. THE PATIENT DID NOT KNOW HOW LONG THE SENSOR HAD THE FAILURE. THE PATIENT'S SISTER TOOK THE PATIENT TO THE HOSPITAL. UPON ARRIVAL, THE DOCTOR TREATED THE PATIENT WITH IV FLUIDS AND MONITORED THE PATIENT'S BLOOD SUGAR UNTIL THE READINGS STABILIZED FROM 500 MG/DL TO 110 MG/DL. THE PATIENT SLEPT IN THE HOSPITAL OVERNIGHT AND WAS RELEASED THE FOLLOWING MORNING AT 10:00AM. AT THE TIME OF THE REPORT, THE PATIENT WAS IN NORMAL CONDITION. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350115 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1825053005 00386270003935

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Other INSULIN PUMP