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

Lot Number 7278683

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Skin Irritation (2076); Burning Sensation (2146); Skin Tears (2516); Contact Dermatitis (4546)

Event Type  Injury  

Event Description

In use of the dexcom g6, the past 2 sensors i have used seriously damaged my skin.The adhesive has given me dermatitis, as diagnosed from the dermatologist i visited/had to receive a prescription cream for it.In the past, use of the dexcom would only leave a small bump from where the needle/wire was inserted into my arm.Other type 1 diabetics i know report the same issue.Starting this summer.The adhesive leaves my skin painfully raw, itchy, red, stinging, and hard to the touch, with multiple scabs (approx 20-30 small ones per dexcom use) in the shape of/within the oval shape of the dexcom (about 2 inches).It has not healed in the 2 weeks since i removed the first sensor, nor in the 3 days since i removed the second sensor.I contacted dexcom customer service and was simply told that their adhesive was medically tested/met standards, and i asked that my complaint/need for a doctor's visit/prescription be recorded.I'm left with no choice but to continue use of the dexcom at risk of the skin on my arms lest my blood sugar control worsen.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11261129
• MDR Text Key: 230057161
• Report Number: MW5099117
• Device Sequence Number: 2
• 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: 01/27/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/04/2021
• Device Lot Number: 7278683
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 66