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

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)

Event Date 06/01/2020

Event Type  Injury  

Event Description

My (b)(6) year old daughter wears a dexcom g6 continuous glucose monitor for her type 1 diabetes.These devices require inserting a sensor into the skin and the sensor is held in place with an adhesive patch that's connected to the sensor.Around the beginning of summer 2020, with a new delivery of sensors from dexcom, my daughter started having a serious adverse reaction to the adhesive on the sensors.It creates a bright red itchy and weeping welt on her arm in the exact shape of the sensor patch.We also had to take the sensors off early as they were itching too bad.I saw posts on a diabetes (b)(6) page of others having the same problem and they noted dexcom had changed their adhesive.Reading that i called and reported it to dexcom.The rep i spoke to confirmed they had changed their adhesive and they were aware of the problem.We continue to get these sensors that cause the same problem and have had to start buying duoderm patches to wear under the dexcom.However, i need to cut a hole in that patch for the sensor to insert through and my daughter still gets a red welt where that cut out is located.So i know dexcom hasn't fixed the problem.This worries me that whatever is in the new adhesive could also be leaching into her skin, either just through contact or through the sensor insertion site or through the raw welt that the adhesive is creating.My daughter's endocrinologist has also had to prescribe a steroid cream to put on these welts to help them heal.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10829088
• MDR Text Key: 216191162
• Report Number: MW5097787
• 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: 11/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2021
• Device Model Number: G6
• Device Catalogue Number: 9500-45
• Device Lot Number: 5276195
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Weight: 39