BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 23022592 · Received September 10, 2025

    Report

    Report Number
    3004753838-2025-254171
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    August 27, 2025
    Report Date
    September 10, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). LABELING INDICATES: INSERTING THE SENSOR AND WEARING THE ADHESIVE PATCH MIGHT CAUSE INFECTION, BLEEDING, PAIN OR SKIN IRRITATIONS (E.G. REDNESS, SWELLING, BRUISING, ITCHING, SCARRING OR SKIN DISCOLORATION).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SKIN REACTION ISSUE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. THE PATIENT EXPERIENCED A SKIN REACTION AND INFECTION THAT DEVELOPED SEVEN DAYS AFTER SENSOR INSERTION IN THE ARM. THE AREA HAD BEEN PREPPED WITH ALCOHOL PRIOR TO INSERTION. THE PATIENT REPORTED SYMPTOMS INCLUDING RASH, REDNESS, INFLAMMATION, AND AN INFECTION EXTENDING BEYOND THE PATCH PERIMETER. ON (B)(6) 2025, THE PATIENT CONSULTED A PHYSICIAN, WHO PRESCRIBED DOXYCYCLINE HYC 100 MG, TO BE TAKEN TWICE DAILY. IT WAS UNSPECIFIED WHETHER THE SYMPTOMS ORIGINATED AT THE NEEDLE PUNCTURE SITE OR BENEATH THE SENSOR PATCH, AND THE PATIENT¿S CONDITION FOLLOWING TREATMENT WAS NOT REPORTED. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE 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
    1777654 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other