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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Scar Tissue (2060); Skin Inflammation/ Irritation (4545)

Event Date 03/05/2022

Event Type  Injury  

Event Description

My original response timed out, so i'm going to respond with a quicker answer.I now have skin irritations and pain due to the use of dexcom.This didn't happen right away.I was recently diagnosed diabetic in (b)(6) 2021.My primary doctor referred me to a diabetic educator and she's the person who set me up with dexcom.When i was receiving these units from her, i never had skin issues.Then i started buying them once my insurance kicked in and started paying towards them, i began showing signs of almost allergic reactions.I wondered if between (b)(6) 2021 and now, (b)(6) 2022, if dexcom changed their product.I have sent them multiple emails and called them a few times.Here's my last response by email ((b)(6) 2022).Hello (b)(6), thank you for your response.We have updated your complaint with the information you provided in your response.Apologies for the inconvenience and we will make sure to keep an eye on this.In case there are information you need to know, we will call you and get in touch.To be transparent as possible, we had a slight change in the adhesive formula, but the patches don't contain latex, and they are medical-grade, pressure-sensitive, acrylic-based adhesive, just like the previous patch.We will be sending the replacement/s for the following: 3 g6 sensors you will receive a confirmation email with tracking information once the replacement has been shipped.It may take 3-5 business days for the shipment to arrive.Kindly visit our website with the following helpful links www.Dexcom.Com/faq/removal-techniques www.Dexcom.Com/faq/sensitive-skin you may visit the dexcom help center at https://www.Dexcom.Com/faqs to answer your questions regarding your concern.If you require immediate assistance, please contact us at 844-607-8398 and provide the case number(s): 220308- 005513 220308-008763 220308-008764 220308-008765 or for future reference you can also try other channels by clicking the link below.Request a call back from a representative request sensor over patches chat live with dexcom tech support (at this time, live chat is only available to us customers, monday-sunday from 5am-5pm pst.) thank you again for contacting dexcom global technical support.Sincerely, (b)(6) dexcom global technical support answers to common issues: https://www.Dexcom.Com/faqs apparently dexcom has changed their "adhesives", hence the reason for the skin irritations and pain.Fyi - there is a whole group on facebook dedicated to this issue.Dexcom was made aware apparently, but claims that this issue is still very "rare" amongst the diabetic community.I have photos of my skin irritations, but this site won't accept them.Plus i reached out to my educator as well.For the price of the dexcom units, i really wish they would fix these problems.We as diabetics are already facing health struggles, why add to it, with now having "skin irritations" and pain, scarring, etc.Due to dexcom changing their ways? i'm on the verge of giving up on dexcom myself.At first it was worth having my blood sugars read well and through usage on my phone, sharing with my doctors, it seemed like a wonderful device.Now that i'm having problems, it's just the same responses every time and people are talking about it.I haven't had lab work done, due to my skin irritations, but my diabetic educator is aware.I also have photos, but this site won't allow them, too large.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: 13949629
• MDR Text Key: 288362432
• Report Number: MW5108609
• 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: 03/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ACTIVE LIVER TABLET; APPLE CIDER VINEGAR CAPSULES; BABY ASPIRIN; BIOTIN; CARLSON'S FISH OIL CAPSULES; ESTRADIOL; FLORAJEN3; FLUCANOZOLE; LASIX; LIVE CONSICIOUS POWDERED COLLAGEN; SPRINOLACTANE; VITAFUSION MULTIVITAMIN GUMMY; VITAMIN D3
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White