BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6347579 · Received February 21, 2017

    Report

    Report Number
    3004753838-2017-10985
    Event Type
    Injury
    Date Received
    February 21, 2017
    Date of Event
    December 6, 2016
    Report Date
    January 30, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    10386270000016
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE USER'S GUIDE STATES: INSERTING THE SENSOR AND WEARING THE ADHESIVE PATCH MIGHT CAUSE INFECTION, BLEEDING, PAIN OR SKIN IRRITATIONS (REDNESS, SWELLING, BRUISING, ITCHING, SCARRING OR SKIN DISCOLORATION). THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF. PRODUCT CODE PQF IS NOT CURRENTLY AVAILABLE IN FIELD D.2B.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT ON (B)(6) 2017, THAT THE PATIENT EXPERIENCED A SKIN REACTION. THE SENSOR WAS INSERTED AT THE LEG. THE REACTION WAS DESCRIBED AS VERY RED, ITCHY, RAISED, AND GETS VERY RAW AFTER ONE (1) WEEK. AFFECTED AREA WAS TREATED WITH UNSPECIFIED TOPICAL ANTI-INFLAMMATORY AGENT. AFFECTED AREA WAS ALSO TREATED WITH AN OVER-THE-COUNTER NASAL SPRAY CALLED NASAL CORE THAT WAS PRESCRIBED (B)(6) 2017. AT TIME OF CONTACT, THE NASAL SPRAY IS REPORTED TO BE HELPING THE PATIENT. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS PROVIDED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE SENSOR WAS INSERTED INTO THE LEG. LABELING INDICATES: DO NOT INSERT THE SENSOR IN SITES OTHER THAN THE BELLY (ABDOMEN) OR UPPER BUTTOCKS. USE IN OTHER SITES MIGHT CAUSE SENSOR GLUCOSE READINGS TO BE INACCURATE AND COULD RESULT IN YOU MISSING SEVERE HYPOGLYCEMIA (LOW BLOOD GLUCOSE) OR HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128605 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 NI 10386270000016

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other