MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR; SENSOR, GLUCOSE, INVASIVE

Model Number G6

Device Problems Loss of or Failure to Bond (1068); Incorrect, Inadequate or Imprecise Result or Readings (1535); Patient-Device Incompatibility (2682); Device Fell (4014)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Scar Tissue (2060); Skin Inflammation/ Irritation (4545)

Event Date 02/19/2021

Event Type  Injury  

Event Description

Welts / itchy rash; i have never had a problem with the adhesive on the dexcom g6 continuous glucose monitor.I have continued to have problems since february 19 when i first reported it to dexcom, and as of today i now have four different rashes on my two arms with one that remains reddish/purplish.I have had to see a dermatologist twice.Dexcom has admitted to changing the chemical formula so that it will adhere for 14 days on their new g7 rather than just the 10 days.The old adhesive worked fine for me and thousands of others.I am on a support group for this on (b)(6) with more than 10,000 people wondering how to get past this.I want dexcom to offer the older adhesive formula because my tandem insulin pump only communicates with dexcom sensors.My dermatologist says it's not an allergy, it's just an irritant.The second sensor with that adhesive lasted only six days before it became unbearably itchy.Then i tried the iv 3000 but the chemicals leached through that causing horrendous pain after only four days of wearing it.I tried one with flonase nasal spray on my skin with the iv 3000 but that did not adhere well and fell off after 1.5 days.I am on day four of my current sensor that had steroid cream with the highest potency on one hour ahead of time, two sprays of flonase, and two layers of skin-tac adhesive barrier wipes all with drying time in between.Then i put the iv 3000 then the sensor through it with no hole punched.I used the dexcom overlay patch to help stick everything down but i'm scared to shower every day for fear it will fall off.My blood sugar readings are now normalized after the first day it was horrible roller coaster.I just miss the old adhesive where i could use one alcohol swab and inject the sensor in two seconds with no fear of a painfully itchy rash that causes permanent scarring.I saw my primary care doctor on march 4 who deals with internal medicine and is fully aware of what's going on with dexcom.He mentioned my possibly needing a steroid cream.I saw the dermatologist on march 5 and again on march 8.I need to purchase hydro colloidal gel bandages which have been out of stock at (b)(6), (b)(6), and even on (b)(6) until just a few days ago (b)(6) got some in.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11495303
• MDR Text Key: 240404056
• Report Number: MW5100007
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000255
• UDI-Public: (01)00386270000255
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/11/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/13/2022
• Device Model Number: G6
• Device Catalogue Number: PN 9500-45 OR STS-OR-001
• Device Lot Number: 5274424
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 53 YR
• Patient Weight: 73