BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 21428053 · Received February 20, 2025

    Report

    Report Number
    3004753838-2025-042235
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    January 3, 2025
    Report Date
    February 24, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    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). B5: DESCRIBE EVENT OR PROBLEM - CORRECTION. B6 RELEVANT TESTS/LABORATORY DATA, INCLU - CORRECTION. G3: DATE RECEIVED BY MFG - CORRECTION. G6: TYPE OF REPORT - UPDATED/FOLLOW-UP. H2: TYPE OF FOLLOW UP - CORRECTION. H10: CORRECTED DATA.

    Description of Event or Problem · 0

    DEXCOM WAS MADE AWARE ON 02/10/2025, THAT ON (B)(6)2025, THE PATIENT EXPERIENCED A SKIN REACTION. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6)2024. ON (B)(6)2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SKIN REACTION WITH AN INFECTION WHICH OCCURRED FIVE DAYS AFTER THE SENSOR HAD BEEN INSERTED IN THE LEFT ARM. THE PATIENT DEVELOPED PIMPLES, PUSTULES, AND AN INFECTION AT THE NEEDLE PUNCTURE SITE. PRIOR TO SENSOR INSERTION THE AREA WAS PREPPED WITH ALCOHOL. ON (B)(6)2025, THE PATIENT CONSULTED HIS PHYSICIAN, AND NO TESTING WAS PERFORMED DURING THE VISIT DUE TO THE PATIENT HAD ALREADY TESTED POSITIVE FOR A STAPH INFECTION AT THE PREVIOUS DEXCOM SENSOR INSERTION SITE ((B)(4) / 250210-009369). THE HEALTH CARE PROFESSIONAL (HCP) PRESCRIBED THE SAME TOPICAL ANTIBIOTIC THAT WAS USED TO TREAT THE TWO PREVIOUS DEXCOM SKIN INFECTIONS (MUPIROCIN 2% CREAM) AND A DIFFERENT ORAL ANTIBIOTIC MEDICATION (DOXYCYCLINE 100 MG, ONE TABLET EVERY 6 HOURS FOR 10 DAYS) WAS PRESCRIBED FOR THIS INFECTION SITE. THE PATIENT WAS ADVISED TO REFRAIN FROM INSERTING A NEW SENSOR UNTIL THE INFECTION SITE HAS HEALED. ON (B)(6)2025, TECH SUPPORT CONTACTED THE PATIENT TO VERIFY ADDITIONAL INFORMATION. AT THE TIME OF THE FOLLOW UP REPORT THE INFECTION SITE HAD ALREADY HEALED. A PHOTOGRAPH WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA PHOTOGRAPHIC INSPECTION. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED. DEXCOM WAS MADE AWARE ON 02/10/2025, THAT ON (B)(6) 2025, THE PATIENT EXPERIENCED A SKIN REACTION. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2024. THE PATIENT EXPERIENCED A SKIN REACTION WITH AN INFECTION WHICH OCCURRED FIVE DAYS AFTER THE SENSOR HAD BEEN INSERTED IN THE LEFT ARM. THE PATIENT DEVELOPED PIMPLES, PUSTULES, AND AN INFECTION AT THE NEEDLE PUNCTURE SITE. PRIOR TO SENSOR INSERTION THE AREA WAS PREPPED WITH ALCOHOL. ON (B)(6) 2025, THE PATIENT CONSULTED HIS PHYSICIAN, AND NO TESTING WAS PERFORMED DURING THE VISIT DUE TO THE PATIENT HAVING ALREADY TESTED POSITIVE FOR A STAPH INFECTION AT THE PREVIOUS DEXCOM SENSOR INSERTION SITE. THE HEALTHCARE PROVIDER (HCP) PRESCRIBED THE SAME TOPICAL ANTIBIOTIC THAT WAS USED TO TREAT THE TWO PREVIOUS DEXCOM SKIN INFECTIONS (MUPIROCIN 2% CREAM) AND A DIFFERENT ORAL ANTIBIOTIC MEDICATION (DOXYCYCLINE 100 MG, ONE TABLET EVERY 6 HOURS FOR 10 DAYS) WAS PRESCRIBED FOR THIS INFECTION SITE. THE PATIENT WAS ADVISED TO REFRAIN FROM INSERTING A NEW SENSOR UNTIL THE INFECTION SITE HAS HEALED. ON (B)(6) 2025, TECHNICAL SUPPORT CONTACTED THE PATIENT TO VERIFY ADDITIONAL INFORMATION. THE PATIENT CONFIRMED THE RELATED SKIN REACTION SITE IN THE ATTACHED LEFT ARM PHOTO IS THE SITE LOCATED ON THE LEFT LOWER TRICEPS AREA. THE PHOTO SHOWS AN OPEN ABSCESS AT THE NEEDLE PUNCTURE SITE THE SIZE OF THE SENSOR DIAMETER. THE REDNESS AND INFLAMMATION EXTENDED BEYOND THE SENSOR PATCH FOOTPRINT PERIMETER. THE PHOTO CONFIRMED THE SKIN REACTION. AT THE TIME OF THE FOLLOW UP REPORT THE INFECTION SITE HAD ALREADY HEALED. A PHOTOGRAPH WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA PHOTOGRAPHIC INSPECTION. 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
    465874 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1824173003

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other