BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 20424397 · Received October 10, 2024

    Report

    Report Number
    3004753838-2024-263106
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 10, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    DEXCOM WAS MADE AWARE ON 09/205/2024, THAT ON THE SAME DAY, THE PATIENT EXPERIENCED A SKIN REACTION. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2024. ON 09/25/2024, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SKIN REACTION WITH BURNING, REDNESS, INFLAMMATION, DRAINAGE, AND INFECTION EXTENDING BEYOND THE PATCH PERIMETER WHICH OCCURRED ON AN UNSPECIFIED DAY AFTER THE SENSOR HAD BEEN INSERTED INTO THE ARM. THE SKIN WAS PREPPED WITH AN ALCOHOL WIPE PRIOR TO SENSOR INSERTION. THE PATIENT WENT TO THE DOCTOR FOR EVALUATION. THE PATIENT DESCRIBED THE AREA AS BEING SWOLLEN TO THE SIZE OF A GRAPEFRUIT, WATERY, AND WARM/TENDER TO THE TOUCH. THE DOCTOR DIAGNOSED THE PATIENT WITH A SKIN INFECTION, TREATED HER WITH A ROCEPHIN INJECTION, AS WELL AS A PRESCRIPTION FOR ORAL DOXYCYCLINE. THE PATIENT WAS ALSO SCHEDULED FOR AN INCISION AND DRAINAGE PROCEDURE ON (B)(6) 2024. UPON FOLLOW-UP WITH THE PATIENT ON (B)(6) 2024, THE PATIENT STATED THAT THE INCISION AND DRAINAGE PROCEDURE WAS NOT DONE, AS THE SKIN REACTION HAD IMPROVED WITH THE MEDICATION SHE WAS PRESCRIBED. THE PATIENT STATED THE AREA WAS ¿BETTER¿ WITH LESS REDNESS, PAIN, TENDERNESS, AND WARMTH AT THE TIME OF FOLLOW-UP. 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
    344705 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1724188002

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Other