BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5728053 · Received June 15, 2016

    Report

    Report Number
    3004753838-2016-03485
    Event Type
    Injury
    Date Received
    June 15, 2016
    Date of Event
    May 15, 2016
    Report Date
    May 20, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: 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 · 1

    PATIENT'S MOTHER CONTACTED DEXCOM ON 05/20/20156 TO REPORT THAT THE PATIENT EXPERIENCED A SKIN REACTION ON (B)(6) 2016. THE SENSOR WAS INSERTED INTO THE BUTTOCKS ON (B)(6) 2016. THE PATIENT'S MOTHER NOTICED RED BUMPS AND A RASH LOCATED UNDER THE SENSOR POD. PATIENT'S MOTHER EMAILED THEIR DOCTOR ON (B)(6) 2016 WITH AN ATTACHED PHOTO OF THE SKIN REACTION. THE DOCTOR EMAILED BACK AND PRESCRIBED KEFLEX 500MG, TO BE TAKEN 3 TIMES A DAY. PATIENT'S REACTION WAS TREATED WITH THE PRESCRIBED KEFLEX. AT THE TIME OF CONTACT, THE RASH WAS HEALING. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380307 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other