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

Model Number 9500-45

Device Problem Product Quality Problem (1506)

Patient Problems Itching Sensation (1943); Skin Discoloration (2074); Skin Irritation (2076)

Event Date 08/19/2020

Event Type  Injury  

Event Description

Hello my name is (b)(6) i am a dexcom g6 cgm user. I have to insert a sensor patch on my skin every 10 days to monitor my blood sugar levels. In the past i have had no problems until recently. The last 2 sensors i have installed have left an oval shape burn or bad skin irritation mark on my skin. I had researched it, and apparently dexcom has changed the adhesive used on the sensor patch. What i feel is my the sensor area itches first then a red ring appears around the patch area. Generally you apply the patch around the abdomen area. Currently i have 2 sites on my abdomen area that are affected. I have pictures of both patch areas. And a picture of the packaging. The 1st patch area i have been putting burn ointment on it. I believe there will be permanent scars. I had older sensors which i installed yesterday (b)(6) 2020 so far i have noticed any irritation yet. I do know they switched adhesives on dexcom g6 cgm sensor patch, so i'm hoping this older version will not give me a burn. If you have any questions you can contact me at (b)(6). Thank you (b)(6). Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10514364
• MDR Text Key: 206566408
• Report Number: MW5096522
• Device Sequence Number: 2
• 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: 09/08/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9500-45
• Device Catalogue Number: 9500-45
• Device Lot Number: 7268142
• 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?

Type of Device Usage

Patient Treatment Data

Date Received: 09/09/2020 Patient Sequence Number: 1