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

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

Patient Problems Erythema (1840); Itching Sensation (1943); Skin Irritation (2076); Swelling (2091); Reaction (2414)

Event Date 04/01/2020

Event Type  Injury  

Event Description

I have been wearing a dexcom g6 glucose sensor for years. I have never had any skin problems with the adhesive until about a couple of months ago. Around that time i started getting skin reactions around the dexcom sensor site. The reaction was itchy skin, redness of skin under the adhesive and red irritated red bumps under the adhesive site as well. The last skin reaction was severe and i had to go to the doctor for treatment. I called the dexcom company and was told they recently changed the adhesive as they were having problems with the adhesive not adhering to the skin. Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10178968
• MDR Text Key: 196136395
• Report Number: MW5095105
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 06/19/2020 Patient Sequence Number: 1