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

Device Problem Contamination (1120)

Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Swelling (2091); Tissue Damage (2104); Burning Sensation (2146); Reaction (2414)

Event Date 02/18/2020

Event Type  Injury  

Event Description

I have been on the dexcom for over 10 years.The last sensor i wore started itching really bad on day 5 of wear.I continued to wear for the entire 10 day period.Around day 8 my skin under the adhesive started oozing.I attached a picture.When i removed it, my skin was burning and very painful.It was bright red and had tiny bumps all over.I put hydrocortisone on it.About a day later, my skin started peeling similar to a sun burn and felt extremely dry.I have been ¿along¿ lotion daily and it is still dry and itchy and red.My current sensor is also doing the same thing.Itchy and residue around the edges.I know this has to be a change in the adhesive because i¿ve never had a reaction like this before or had this nasty residue in all the years using.Do you have a picture of this product? yes.Fda safety report id # (b)(4).

• Brand Name: G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 9775066
• MDR Text Key: 181771814
• Report Number: MW5093421
• 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: 02/26/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 66