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

Model Number 5275431

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Skin Irritation (2076)

Event Date 09/21/2020

Event Type  Injury  

Event Description

I have been a long time user of dexcom continous glucose monitoring.Since the summer i have noticed a sudden onset rash and extreme skin irritation.In speaking with dexcom they admitted there was a change to their adhesive formula and admitted they were seeing many calls on this topic but had no plans to revert back to the previous adhesive.The issue is that the dexcom is worn for 10 days, for me, the itching begins within a day of insertion, and by the time the dexcom sensor is changed their severe skin damage.As a diabetic, any form of a wound is of concern and these dexcom sensor welts are taking 4-6 weeks to heal.These sensors are worn on the abdomen so in a rotation of locations you eventually need to use an insertion site that is not fully healed.I fear there will be scaring due to this change in the adhesive.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10573913
• MDR Text Key: 208359631
• Report Number: MW5096818
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2021
• Device Model Number: 5275431
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 40 YR
• Patient Weight: 79