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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abrasion (1689); Erythema (1840); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Scarring (2061); Skin Burning Sensation (4540)

Event Date 11/07/2020

Event Type  Injury  

Event Description

I started the dexcom g6 sensor about two months ago.My first one, i lasted 7 days before itching started.I had to remove on either the 8th or 9th day of the 10-day sensor before it got so painful that i had to remove it.My skin under the adhesive peel was bright red, raised and bumpy, itchy, burning and some parts were so raw i was bleeding.I treated with antibiotic cream and lotion and today, i have a gray/brown ovular scar where that site was.About six days ago i said let me try again because the first time i used a barrier adhesive for it to stick better, so i thought it was that.I didn't use the adhesive this time.On saturday the 7th, i had to remove due to the unbearable itching again.This time, i had all the same symptoms (bumps, burning, raw skin) in a perfect oval, but also a new symptom: the sticky part of the transmitter (what comes on the actual site you inject) had a yellow fluid spotted on it, indicating infection of the open wound.I have been treating with antibiotic cream and keeping the area clean and dry by washing every six hours and redoing my dressing.I am sure this will scar as well.It is embarrassing and i just moved to (b)(6) from (b)(6) to enjoy the beach and weather with my fiancé, and now i cannot wear a bikini or crop top because of my embarrassing bright red infected abdomen.This is making me tear up as i write this.Please look into this.Dexcom transferred me back and forth between technical support and customer service- technical gave me their own url link to their "sensitive skin" page, and service told me to contact my doctor because "i must be allergic." there are forums on diabetic blogs and (b)(6) about others who have suffered adverse reactions to the dexcom g6, ranging from mild itching to permanent scars (including me).Please help.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10836638
• MDR Text Key: 216338639
• Report Number: MW5097834
• 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: 11/09/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 23 YR