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

Lot Number 7316289

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Blister (4537); Localized Skin Lesion (4542)

Event Date 12/10/2022

Event Type  Injury  

Event Description

For they past 3 years using dexcom g6 sensors i have had no issues with skin reactions, until this past month.The last 3 dexcom g6 sensors i have used have left sores/blisters and redness directly under the transmitter carriage.I have had no skin reactions outside of the area, where the rest of the adhesive tape/patch lies.I have reported the issue to dexcom.I am more deeply concerned because there are online forms, groups and chats with many people experiencing the same issue.

• Brand Name: DEXCOM G6 GLUCOSE SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 15979981
• MDR Text Key: 305559283
• Report Number: MW5113779
• Device Sequence Number: 2
• Product Code: MDS
• Combination Product (y/n): N
• 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: 12/11/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 7316289
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 50 KG