BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 24048957 · Received January 12, 2026

    Report

    Report Number
    3004753838-2026-034261
    Event Type
    Injury
    Date Received
    January 12, 2026
    Date of Event
    December 30, 2025
    Report Date
    January 12, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004116
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SKIN REACTION OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. THE PATIENT REPORTED EXPERIENCING AN ITCHING SENSATION AT THE SENSOR INSERTION SITE AND OBSERVED YELLOW DRAINAGE LEAKING THROUGH THE OVERLAY PATCH, WHICH LED THEM TO REMOVE THE SENSOR EARLIER THAN INTENDED. UPON REMOVAL, THE PATIENT NOTED SIGNS OF INFECTION, INCLUDING REDNESS, A RASH, YELLOW DRAINAGE AT THE NEEDLE PUNCTURE SITE, AND BRUISING IN THE SURROUNDING AREA. ON (B)(6) 2025, THE SYMPTOMS WORSENED, PROMPTING THE PATIENT TO SEEK CARE AT THE EMERGENCY ROOM (ER). IN THE ER, THE PATIENT WAS EVALUATED AND DIAGNOSED WITH AN ABSCESS AT THE NEEDLE PUNCTURE SITE. THEY WERE PRESCRIBED A 10-DAY COURSE OF ORAL ANTIBIOTICS (BACTRIM SMZ 160/800 MG, TWICE DAILY) AND BEGAN TREATMENT ON (B)(6) 2025. NO LABORATORY TESTS OR DIAGNOSTIC IMAGING WERE PERFORMED, AND THE PATIENT WAS DISCHARGED HOME THE SAME DAY. AT THE TIME OF THIS REPORT, THE PATIENT CONTINUES TO EXPERIENCE REDNESS, DRAINAGE, AND BRUISING AT THE INSERTION SITE. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. 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
    111048 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1825248012 00386270004116

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Other