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

Lot Number 5278420

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Rash (2033)

Event Date 12/28/2020

Event Type  Injury  

Event Description

I am a long time user of the dexcom g6 continuous glucose monitor.I use this product to help manage my type one diabetes.In august, i noticed a rash develop underneath my skin below the dexcom.This was not normal, so i attributed it to being a faulty unit or a mistake on my part.Since august, i have developed a rash from every dexcom g6 cgm i have used.I have contacted dexcom with the issue, and they are refusing to help customers with this issue.There is currently a (b)(6) petition with nearly 5000 signatures ((b)(6)) asking dexcom to change the adhesive.The rashes developed from the product ooze pus and last for over a week after the product is removed.Thousands of users experience this issue from normal use of the dexcom g6 cgm, and dexcom is offering no recourse except for replacing the product with a new one that will create the same rash, and they refuse to change the adhesive.Fda safety report id# (b)(4).

• Brand Name: G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11100401
• MDR Text Key: 224810350
• Report Number: MW5098583
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/22/2021
• Device Lot Number: 5278420
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 70