BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22686756 · Received August 1, 2025

    Report

    Report Number
    3004753838-2025-206624
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    March 11, 2025
    Report Date
    August 1, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270003935
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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).

    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. ON APPROXIMATELY (B)(6) 2025, THE PATIENT DEVELOPED REDNESS AND A RASH ALONG THE SENSOR PATCH PERIMETER. ON (B)(6) 2025, THE PATIENT FELT DISCOMFORT IN THE AREA AND DECIDED TO REMOVE THE SENSOR EARLY, BUT HE DID NOT MAKE ANY TREATMENT DECISIONS. LATER THAT DAY, A BUMP DEVELOPED WITHIN THE SENSOR PATCH FOOTPRINT AND THE RASH SPREAD DOWN HIS LEFT ARM. HE CONSULTED A HEALTHCARE PROVIDER AND WAS ADVISED TO GO TO THE EMERGENCY DEPARTMENT (ED). IN THE ED, HE WAS EVALUATED, DIAGNOSED WITH CELLULITIS, AND HOSPITALIZED FOR SEVEN DAYS FOR INTRAVENOUS UNSPECIFIED ANTIBIOTIC THERAPY. THE SPECIFIC DIAGNOSTIC TESTS CONDUCTED TO IDENTIFY THE CELLULITIS WERE NOT MENTIONED. AT THE TIME OF THE REPORT THE PATIENT STILL HAD A BUMP IN THE AREA. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238801 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1825014002 00386270003935

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other| H