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

Model Number DEXCOM G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Skin Irritation (2076); Impaired Healing (2378)

Event Date 07/30/2020

Event Type  Injury  

Event Description

Dexcom g6 sensors have new or enhanced adhesive formulation.Sensors are required to last 10 days.Sensors will only last 4-5 days due to severe skin irritation.Area extremely inflamed and itchy.Upon removing sensor, skin is raw and weepy.Takes 3-4 weeks for skin to heal.Have heard reports of same issue occurring with many other dexcom g6 users.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: 10361579
• MDR Text Key: 201762748
• Report Number: MW5095857
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000255
• UDI-Public: 0100386270000255
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/17/2021
• Device Model Number: DEXCOM G6
• Device Lot Number: 5273487
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 86