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

Model Number DEXCOM G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Disorders (4543)

Event Date 02/26/2021

Event Type  Injury  

Event Description

I've been using dexcom continuous glucose monitor's, cgm, since 2017.No health side effects until i retired in (b)(6) 2021 and began walking 5 miles per day (roughly 5 times each week).The significant to severe contact dermatitis happened in (b)(6), 2021 when using 4 consecutive cgm sensors as provided by dexcom (tape/adhesive is the bad actor/culprit) from (b)(6) 2021 until (b)(6) 2021.I now remove and replace the dexcom sensor tape from each new sensor and attach an approved off the shelf medical tape (opsite flexifit tape) in it's place.The newly attached tape has to carefully and permanently be attached to the new sensor module with a specialty adhesive.This tape replacement (opsite flexifit tape) allows me to use the dexcom g6 sensor/cgm without any contact dermatitis side effects that was significant to severe when using the g6 sensor with dexcom tape attached as received from the dexcom.There are many reports and photos of people developing these significant skin rashes from the dexcom tape system.Often, significant modifications are taken from those effected individuals in order for them to keep using the dexcom cgm's.Check out the (b)(4) group called "dexcom and libre rash" group.It's a group for people who are dealing with contact dermatitis (skin rash) from dexcom and abbott libre cgm's.There are a few other websites that have users who post comments, questions and solutions regarding the same skin rash topic from the dexcom and libre cgm's.I am a type 1/insulin dependent diabetic ((b)(6)) and also a retired research technician with (b)(6) of combined experience with a global adhesive manufacturer, (b)(4) and a medical device company (boston scientific).I have no known/diagnosed allergies or sensitivities.I've been tested for allergies at the university of minnesota clinic, the (b)(6) hospital and the (b)(6) clinic when battling a chronic sinus infection.That's another discussion of how i resolved that chronic sinus infection using a dollar store hand soap to kill the infecting agent in my sinus cavity.Please contact me with any questions you have regarding the contact dermatitis adverse reactions from the dexcom g6 cgm's in 2021.Dexcom assigned case # (b)(6).The contact dermatitis was determined to be caused by the dexcom g6 tape by simple deduction.I used the opsite flexifit tape as an overlay tape in order to ensure my cgm would stay attached for the 10 day use period.The contact dermatitis was only present underneath the dexcom tape and never under the opsite flexifit tape.The opsite flexifit tape also covered a wider area of skin to ensure cgm securement.I even placed a 10x7cm film of opsite flexifit tape to my skin as a barrier underlayer and then applied the dexcom g6 cgm with it's tape on top of the barrier layer hoping this would prevent the skin rash.Unfortunately, the skin rash was once again only present underneath the dexcom tape and never the larger flexifit tape, except where the dexcom tape/cgm was attached to the barrier tape (optsite flexifit tape).I was a participant in the mayo clinic international diabetes closed loop clinical study).Fda safety report id # 567667(b)(6).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11975626
• MDR Text Key: 256456817
• Report Number: MW5101804
• Device Sequence Number: 1
• Product Code: MDS
• 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: 06/08/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DEXCOM G6
• Device Catalogue Number: 9500-45
• 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: 57 YR
• Patient Weight: 75