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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Swelling (2091); Burning Sensation (2146)

Event Date 05/04/2020

Event Type  Injury  

Event Description

Severe chemical type rash; applied dexcom sensor, very soon after application the site became extremely itchy which i never experienced before.I took doses of benadryl throughout the 10 day wear session and applied antihistamine itch cream around the area.When i took the dexcom patch/sensor off my skin was left with red blisters, rash and almost appears to be scarred.Now that i have applied the next sensor i am having the same burning and severe itching sensations on another location in my body and am afraid my skin is also being harmed in the same manner.I have never had a problem with the dexcom device until recently so it appears as if something has changed to cause such drastic allergic type reactions.Fda safety report id# (b)(4).

• Brand Name: DEXCOM, G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10061145
• MDR Text Key: 191252887
• Report Number: MW5094503
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/13/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 51