BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 23154950 · Received September 26, 2025

    Report

    Report Number
    3004753838-2025-271705
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    September 5, 2025
    Report Date
    September 26, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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) 2025. ON (B)(6) 2025, THE PATIENT FELT PAIN AT THE NEEDLE INSERTION SITE AND OPTED TO TAKE OUT THE SENSOR EARLY. ON (B)(6) 2025, THE REDNESS WORSENED AND HE EXPERIENCED SWELLING AND FLUID DRAINAGE IN THE AREA. ON THAT SAME DAY, HE CONSULTED WITH HIS PRIMARY CARE PHYSICIAN (PCP) AND THE NURSING STAFF, DURING WHICH A SKIN ASSESSMENT TOOK PLACE, AN ABSCESS WAS NOTED, AND HE WAS PRESCRIBED AN ORAL ANTIBIOTIC (SULFAMETHOXAZOLE-TMP 800-260 MG, TO BE TAKEN TWICE DAILY FOR AN INDEFINITE PERIOD) FOR TREATMENT. HE WAS INSTRUCTED NOT TO SQUEEZE THE DRAINAGE OUT AND TO COME BACK FOR A FOLLOW-UP APPOINTMENT. THE PATIENT RETURNED FIVE DAYS LATER AS RECOMMENDED, AND THE PCP DECIDED AGAINST DRAINING THE ABSCESS SINCE THE AREA HAD DECREASED IN SIZE AND FLATTENED FOLLOWING THE ANTIBIOTIC TREATMENT. AT THE TIME OF THE REPORT, THE PATIENT STATED HE WAS IN A NEW SENSOR SESSION AND WAS DOING WELL. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301320 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1725139002

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other