MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM CONTINUOUS GLUCOSE MONITOR 6; SENSOR, GLUCOSE, INVASIVE

Lot Number 5276784

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 07/31/2020

Event Type  Injury  

Event Description

Ongoing rash and irritation; my (b)(6) year old son has been using a dexcom continuous glucose monitor since 2018 with no issue until this summer.We are currently using the g6.He started to have a rash and irritation under the adhesive used to secure the product on his arm or upper butt, the locations approved for use.I assumed it was due to sun and/or exposure to the pool at camp.However, the rash continued even after the summer and persists to this day.We have tried using flonase and tegaderm as barriers between the adhesive and the skin and the rash is getting worse.It is accompanied with intense itching.This is problematic because it is vital that we rotate use locations and the rash is not healing enough to reuse as an injection site in between applications.I reported this to our endocrinologist and she said she had not heard of this and recommended flonase which has proven to be ineffectual.Dexcom is a wonderful product that allows us to have safe monitoring of his blood sugar.I am very concerned the adverse reactions will discourage him from using it in the future or render us unable to use it because the reactions are growing in severity.Fda safety report id#: (b)(4).

• Brand Name: DEXCOM CONTINUOUS GLUCOSE MONITOR 6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11243390
• MDR Text Key: 229644343
• Report Number: MW5099047
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/20/2021
• Device Lot Number: 5276784
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR
• Patient Weight: 27