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

Lot Number 5273489

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Itching Sensation (1943); Burning Sensation (2146)

Event Date 08/13/2020

Event Type  Injury  

Event Description

I have been using the dexcom g6 for about two years with no issues.Starting in (b)(6) of this year, my sensor location started burning, itching, and occasionally bruising.I called them to ask about it and they said they changed the adhesive ingredients to make it less likely to fall off.I have tried multiple remedies and ways to put a barrier between my skin and the adhesive, such as flonase (recommended on their website), using a tegaderm bandage underneath the sensor (recommended on their website) so it isn't in direct contact with my skin, and using skin tac adhesive barrier (also recommended on their website).Even when using all three of those methods independently and combined, nothing is making it better and there is still an itching, burning rash that occurs directly underneath the dexcom sensor from the adhesive.I do not get rashes from any other type of adhesive and have no known allergies.When i contacted dexcom i was told that about 1-2% of their costumers will get the rash and they have no knowledge of the company having plans to change the adhesive.I have seen all over social media multiple complaints with the new issues with rashes, which makes the percent they gave me over the phone seem made up.The dexcom g6 is an expensive medical device, and it is unacceptable that the ingredients in the adhesive are so strong that people without sensitive skin are receiving rashes so bad that they are scaring.Diabetics have a hard time healing, and a device they use to help manage their diabetes better shouldn't come with these issues that are not disclosed anywhere on their website or pamphlets in the box.The ingredients need to be publicly discloses and the adhesive issue needs to be corrected.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: 10425076
• MDR Text Key: 203655574
• Report Number: MW5096117
• 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: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 5273489
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR