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: No Information
• Device Model Number: 9500-45
• Device Catalogue Number: 9500-45
• Device Lot Number: 7268142
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 115