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

Model Number G6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033)

Event Date 12/01/2020

Event Type  Injury  

Event Description

In october 2019, dexcom switched the adhesive they used on their g6 sensor to a different manufacturer, causing many long-term users to suffer a painful, itchy, and sometimes infected rash.This has been well documented on the internet and has even started a petition, as this issue needs to be taken more seriously.The link to the petition is here: https://www.Change.Org/p/dexcom-change-your-adhesive-on-your-devices.| below is a recent response from dexcom regarding the issue, which most, including myself, are not satisfied with.Had this product been submitted to the fda for approval with the current adhesive, i feel it would not have passed inspection, you can easily google pictures online to see the damaging effects of what i believe was a cost saving measure dexcom made without any valid testing, as opposed to an "improvement for the g6 sensor" as dexcom has claimed.| dexcom statement - a new adhesive patch was implemented for the g6 sensor to improve patch performance and reliability in october 2019.All g6 sensors have the new patch material.We have seen significant benefit of this change for most patients; however, we are aware of a smaller number of patients challenged with varying degrees of skin irritation resulting in an increase in the complaint rate for skin irritation.The risk associated is acute allergic or irritant contact dermatitis causing skin irritation that may result in symptoms such as itching, burning, and/or rashes at the site of adhesive patch application.These rashes are infrequent but at times may be severe and the irritation can include redness, swelling, and blistering.The symptoms and rashes vary greatly and dexcom has received some reports of patients requiring medical intervention associated with the skin irritation.The risk of skin irritation leading to hospitalization is unlikely.The risk of skin irritation is inherent in any product with an adhesive component and there are some patients for whom the product will not be suitable.As manufacturers our aim is to produce a device that can work for as many patients as possible and to provide appropriate support and assistance to those patients for whom the device is not suitable.As we continue looking at ways to make our devices a usable option for more of the patient population, we are aware that 3rd party barrier creams or patches have helped some patients who would not otherwise be able to use the g6.Please visit the faq section of our website at www.Dexcom.Com for more information.We have not tested or validated these possible solutions, which will be specific to each individual patient and for that reason, the use of barrier creams or patches needs to be determined by these best placed to assess your individual needs.It may be important to discuss your individual situation and needs with your healthcare professional, as well as the short-term and long-term health effects of skin irritation.Fda safety report id# (b)(4).

• Brand Name: G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11064819
• MDR Text Key: 223608906
• Report Number: MW5098496
• 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
• Type of Report: Initial
• Report Date: 12/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G6
• 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: 43 YR
• Patient Weight: 136