BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 24106456 · Received January 17, 2026

    Report

    Report Number
    3004753838-2026-053243
    Event Type
    Injury
    Date Received
    January 17, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 17, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004109
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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" OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2026. ON 01/005/2026, IT WAS REPORTED THAT THE PATIENT EXPERIENCED INACCURATE READINGS AND HAD SORENESS AT THE INSERTION SITE, LEADING HER TO REMOVE THE SENSOR EARLY. UPON SENSOR REMOVAL, SHE NOTICED REDNESS, INFLAMMATION/SWELLING, AND DRAINAGE AT THE NEEDLE PUNCTURE SITE. ON THE SAME DAY, CONCERNED ABOUT THE WORSENING SYMPTOMS, THE PATIENT CONSULTED A PHYSICIAN WHO ASSESSED THE SITE, OBSERVED AN INFECTION AT THE NEEDLE PUNCTURE SITE, AND PRESCRIBED AN ORAL ANTIBIOTIC MEDICATION. THE PATIENT COULD NOT RECALL THE NAME, DOSAGE, OR DURATION OF THE ANTIBIOTIC TREATMENT. NO WOUND CULTURE OR LABORATORY TESTS WERE PERFORMED AND NO OUTPATIENT WOUND CARE WAS REQUIRED. AT THE TIME OF THE REPORT, THE PATIENT STATED THAT THE NEEDLE PUNCTURE SITE HAD ALREADY COMPLETELY HEALED AND SHE WAS DOING WELL. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND THE PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167087 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1725259003 00386270004109

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Other