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

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Erythema (1840); Inflammation (1932); Itching Sensation (1943); Scarring (2061); Skin Irritation (2076); Caustic/Chemical Burns (2549)

Event Date 05/12/2020

Event Type  Injury  

Event Description

The adhesive on a dexcom continuous glucose monitor (cgm) was changed by the company without any notification for its users.I had been using dexcoms continuously for three years with zero skin reactions to the adhesive.The sensor was on for 10 days, and i started noticing itchiness about 5 days in but didn't think much of it.The adhesive started to peel up at around 9 days, which is typical, and i noticed that the skin underneath was red and irritated.I removed the sensor, and upon pulling it off, discovered that there was a chemical burn in the shape of the dexcom on the back of my arm.The entire area of my skin was raised, inflamed, and bumpy.Upon touching the area with my hand, some of the bumps burst open and pus came out.The entire area was still itchy and red for weeks after removal.The area of skin scabbed over and flaked off but never returned to the correct texture.Since dexcom did not notify anyone about an adhesive change, i chalked it up to putting that sensor on a spot too quickly after having another sensor on previously (it's recommended that you rotate "sites" on your body where the sensor goes, which i do religiously).I put on another sensor on my other arm and experienced the same problem.I've been trying to find a way to reduce the skin irritation but keep my dexcom because it vastly improves my blood sugars as a type 1 diabetic.In the process of trying different methods suggested to me by dexcom, i now have two more faint scars on my stomach in addition to the glaringly obviously dark scars on the backs of both of my arms.I've visited a dermatologist in an attempt to repair the skin that's been damaged.I called dexcom after the second adhesive and asked if anything was changed.Tech support said that there was no change in adhesive.After sending more emails, i received a call on june 5th from someone conducting an investigation on behalf of dexcom, stating there was indeed a change in late 2019.There was no notification from dexcom that they would change the adhesive on their medical product that sits on the skin for 10 days at a time.I likely would have removed the first dexcom halfway through the session had i known that something had been changed, and i could've potentially avoided multiple scars in the shape of dexcom sensors all over my body.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: 10189121
• MDR Text Key: 196584854
• Report Number: MW5095170
• Device Sequence Number: 2
• 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: 06/19/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G6
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 61