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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943); Pain (1994); Rash (2033); Reaction (2414); Blister (4537)

Event Date 01/17/2021

Event Type  Injury  

Event Description

I have developed an adverse reaction to the dexcom g6 cgm sensor.I replace it every ten days, and about twenty days ago when i took the old one off my arm, i noticed that the skin under the sensor was more red and irritated than usual (i've been using dexcom g6 for over two years).I decided to change the insertion site and put the new sensor on my stomach.Within the ten days that followed, the skin under the sensor felt very itchy and the old sensor site on my arm remained red and irritated.When i took the sensor off my stomach ten days ago the skin underneath was raw and covered in red blisters.It looked infected and inflamed.I'd never had a reaction like that before.I still put another sensor on which i am to replace tomorrow.Like the previous two, it caused itchiness and burning.Even the skin around it became red.The previous site on my stomach remained itchy, painful and inflamed for days.It looks like a burn and heals very slowly.All three sensors that caused this adverse reaction were from the same box.I wonder if the manufacturer of dexcom changed the formula of the adhesive on the sensor without warning the consumers.Now i'm torn: i need the cgm to manage my diabetes, but these burn-like patches it leaves me with are not just ghastly to look at; they damage my skin beyond a sustainable level.Thank you.Fda safety report id #: (b)(4).

• Brand Name: SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11250964
• MDR Text Key: 229664985
• Report Number: MW5099088
• Device Sequence Number: 2
• Product Code: MDS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/26/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 64