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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Rash (2033); Caustic/Chemical Burns (2549); Blister (4537); Contact Dermatitis (4546)

Event Date 02/01/2021

Event Type  Injury  

Event Description

My daughter is a type 1 diabetic who began using the dexcom continuous glucose monitoring system last year.For the past six months or more she has had serious skin reactions to the sensors, presumably to the adhesive.Symptoms include a serious red, hot rash, including small fluid-filled blisters and breakage of those blisters.The physical appearance is that of chemical burns or severe contact dermatitis.The rash is painful and itching, each spot takes days or weeks to heal, and we fear that there may be long-term scarring on the worst spots.The benefits of the cgm are sufficiently great that we have been seeking solutions from the online diabetic community rather than discontinuing use.We have tried chemical and physical barriers, some of which have provided marginal relief, but even the best of the solutions tried to date still result in some level of painful, raised rash.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11285382
• MDR Text Key: 230703361
• Report Number: MW5099231
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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: 22 YR