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

Lot Number 5271848

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Irritation (2076); Reaction (2414); Skin Inflammation (2443); Fluid Discharge (2686)

Event Date 07/18/2020

Event Type  Injury  

Event Description

I am a type 1 diabetic.I have been using a dexcom g6 continuous glucose monitor for blood sugar management since (b)(6) 2019.Before (b)(6) 2020, i had great success with the product.However, i was informed by a dexcom representative that they recently made changes to the adhesive formula that they use on their sensor devices.I got a new shipment of sensors in early (b)(6) 2020.I have used four sensors from the new shipment since that time.Each sensor is supposed to stay attached to the skin of the abdomen for ten days at a time.However, i have had problems keeping the new sensors attached and three of the four detached early after only five to nine days.This was not an issue before receiving this new shipment.More importantly, over the course of using the four sensors, i have been left with an increasingly severe rash at the sensor placement site.I do not use the same placement location for each new sensor, i rotate the placement around my abdomen.It has become so severe that after the fourth sensor fell off after only six days, i was left with a large, itchy, inflamed, red rash on my abdomen with my skin broken open and seeping fluids.I have several sensors left, but i have had to discontinue use of the sensors altogether because i fear i am now risking infection.When i called dexcom, they only offered to replace the sensors that fell off early.However, that is of little use to me because i can not use the replacement sensors if they are going to continue to cause such a terrible reaction.Online research has shown me that many, many people are having similar problems with very severe reactions to this irritation.Dexcom told me they are aware of the issues.I have relied on this device for maintain my health and sustain my life.They have not provided any explanation for the changes to their adhesive formula that is causing a significant reduction to many people's quality of life.I have attached an image of the dexcom packaging, as well as the skin reaction i experienced to the third sensor discussed above.My skin's reaction to the fourth sensor was actually when the wound broke the skin and started seeping, but i did not take a picture of it.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: 10338288
• MDR Text Key: 201055985
• Report Number: MW5095775
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• 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: 07/25/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/14/2021
• Device Lot Number: 5271848
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 86