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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Scarring (2061); Skin Burning Sensation (4540)

Event Date 09/16/2020

Event Type  Injury  

Event Description

I have been using dexcom g6 cgm sensors for a couple years and recently i've developed serious allergic reactions to the adhesive, which dexcom acknowledges they've changed around the beginning of this year.I never had allergic reactions to whatever the original adhesive formulation.There have been many similar cases posted by diabetics online and confirmed from a dermatologist who specializes in allergic reactions.The reactions are incredibly itchy and painful, like a burn, and it leaves permanent scarring.Fda safety report id# (b)(4).

Event Description

Additional information received from reporter on october 29, 2020 for report number mw5097523: revision to a previous submission yesterday about a severe allergic reaction to the adhesive on the dexcom g6 cgm sensor.Andrew costello 51 y/o male i forgot to attach the photo so that's what i'm doing now.

• Brand Name: DEXCOM G6 CGM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10755160
• MDR Text Key: 213884401
• Report Number: MW5097523
• 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,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 51 YR
• Patient Weight: 93