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

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Local Reaction (2035)

Event Date 05/17/2020

Event Type  Injury  

Event Description

I am a type 1 diabetic and have been using dexcom cgms for more than 2 years.I recently had a terrible adverse reaction to the adhesive (bleeding, blistering).After several calls to dexcom, they finally admitted they had changed their adhesive formula without notifying their customers.The advice i received from them was "try a new one from the same lot" and "maybe you didn't put it on right." i am a medical professional who has had t1d for many years, and used their sensors for more than 2 years without incident- i was not putting it on incorrectly.I have had to visit a dermatologist several times, who confirmed it is contact dermatitis, and i have permanent scarring.I am disgusted with them for not telling their users of the change to a medical device, and for blaming the user for the problem.Please make them address this issue.Diabetes is hard enough without medical companies withholding pertinent risk information.I have reached out to the company multiple times to try to get more information about the adhesive changes, or to get an explanation from management, but they will not call me back.Furthermore, there is plenty of outcry about this on social media- they are well aware of the problem and are not addressing it.Although t1d affects a small number of people relative to many other conditions, we should not be harmed by our medical devices, this needs to be rectified by dexcom, and their process for notification to users of risks reviewed and amended.Fda safety report id#: (b)(4).

• Brand Name: DEXCOM G6 CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10390357
• MDR Text Key: 202589930
• Report Number: MW5095992
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000866
• UDI-Public: (01)00386270000866
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/19/2020
• Device Model Number: G6
• Device Catalogue Number: REF: STS-OE-003
• Device Lot Number: 5266774
• 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: 33 YR
• Patient Weight: 62