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

Lot Number 5271049

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Skin Irritation (2076); Caustic/Chemical Burns (2549)

Event Date 07/17/2020

Event Type  Injury  

Event Description

Dexcom has recently switched their adhesive on the g6 sensors, which has left me with severe skin irritation.I have been using the g6 for well over a year now, and never had a problem until they switched the formula.It's like a red chemical burn that's left on my skin that remains itchy for multiple days after it has been removed.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: 10326326
• MDR Text Key: 200685478
• Report Number: MW5095729
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/19/2021
• Device Lot Number: 5271049
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 98