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

Lot Number 5275655

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Skin Irritation (2076); Blister (4537)

Event Date 10/07/2020

Event Type  Injury  

Event Description

I have been using the dexcom g6 sensors to monitor my blood glucose since (b)(6) 2020.In the past month, i have been experiencing burns at the application sites.The burns consist of tiny blisters that begin to weep.The irritation has caused hyper pigmented areas to where the sensors have been placed.When i reported it to my insurance company, i was given the following link: (b)(6).I have tried to use some of the recommendations; however, none of them have worked.I attempted to contact dexcom directly at (b)(6) and was told that they did change the formula for the adhesive in (b)(6) 2019.They were not able to provide an actual solution to prevent this from happening again.From researching this matter online, i have been able to see that i am not the only consumer to report this problem to dexcom or the fda.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: 10670025
• MDR Text Key: 211309564
• Report Number: MW5097194
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/29/2021
• Device Lot Number: 5275655
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 81