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

Model Number G6

Device Problem Difficult to Remove (1528)

Patient Problems Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 01/31/2021

Event Type  Injury  

Event Description

Dexcom sensor tape has changed.It's like they're now using super glue.I've used dexcom for 8 years and have never had this issue until now.The glue is so strong, i have difficulty removing the tape at the end of 10 days.It takes a layer of skin off leaving welts and blood blisters after it's removed.I've never experienced this before.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11278711
• MDR Text Key: 230477836
• Report Number: MW5099210
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): Y
• 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: 02/01/2021

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 Expiration Date: 07/10/2021
• Device Model Number: G6
• Device Lot Number: 7277598
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 79