BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22821966 · Received August 15, 2025

    Report

    Report Number
    3004753838-2025-225524
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    August 3, 2025
    Report Date
    August 15, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270001764
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED MALFUNCTION OCCURRED. THE DATE OF THE EVENT IS AN APPROXIMATION. ON (B)(6) 2025, THE PATIENT WAS ATTEMPTING TO ACTIVATE A NEW SENSOR AND TRANSMITTER. WHILE WAITING FOR THE DEVICES TO BEGIN FUNCTIONING, THE PATIENT BEGAN FEELING UNWELL LATER IN THE AFTERNOON. SHE REPORTED EXPERIENCING SIGNIFICANT CONFUSION AND WAS UNABLE TO RECALL EVENTS FOLLOWING HER DECISION TO CALL AN UBER FOR ASSISTANCE. ACCORDING TO THE PATIENT, THE UBER DRIVER CONTACTED EMERGENCY SERVICES, AND AN AMBULANCE WAS DISPATCHED. THE PATIENT WAS UNABLE TO PERFORM A FINGERSTICK TEST PRIOR TO HOSPITAL ARRIVAL. UPON ADMISSION TO THE HOSPITAL, THE PATIENT WAS UNABLE TO RECALL WHETHER A FINGERSTICK TEST WAS PERFORMED, CITING FEELINGS OF RESTRAINT AND DISORIENTATION. SHE WAS DIAGNOSED WITH DIABETIC ACIDOSIS AND RECEIVED TREATMENT INCLUDING AN INSULIN IV DRIP, POTASSIUM, FOLIC ACID, AND OTHER MEDICATIONS, THOUGH SHE COULD NOT RECALL ALL THE SPECIFICS. THE PATIENT WAS DISCHARGED ON 08/08/20258, AT APPROXIMATELY 3:00 PM AND REPORTED FEELING BETTER AT THE TIME OF DISCHARGE. AT THE TIME OF THE REPORT, THE PATIENT WAS FINE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2413008 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI 00386270001764

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Hospitalization| O