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

Model Number DEXCOM G6 SENSOR

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Rash (2033)

Event Date 10/16/2020

Event Type  Injury  

Event Description

I use the dexcom g6 cgm for controlling my type 1 diabetes.Over the past few months, dexcom has changed the adhesive that holds the transmitter and sensor to the skin.The adhesive used now causes a chemical like burn on the skin that takes weeks to heal.This has been a topic on social media for some period of time but no response from dexcom.The product can be unusable due to the burn/rash.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10836464
• MDR Text Key: 216328152
• Report Number: MW5097825
• 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: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• 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 Model Number: DEXCOM G6 SENSOR
• 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: 57 YR
• Patient Weight: 91