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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 08/01/2020

Event Type  Injury  

Event Description

I am getting a rash now from the dexcom 6 sensor adhesive, it started in the last 2 or 3 months.Have tried with and without a tac skin barrier but i still get a rash, tried on my arm on my outer bicep, still a rash, so i guess i either developed this adhesive allergy since i started using dexcom continuous glucose monitor, or they changed there adhesive.I never really had any type of adhesive allergy before.My doctor asked that i put in this complaint, as many of his patients are now having the same reaction.Leading the professionals to believe that they changed the adhesive formulation.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10711991
• MDR Text Key: 212523435
• Report Number: MW5097345
• 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: 10/16/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 113