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

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 10/12/2020

Event Type  Injury  

Event Description

Hello my daughter has been using dexcom to see her blood sugar for almost 5 years.They changed the adhesive which is causing many to have a reaction.I chose the date of (b)(6) but she gets a terrible rash every time we put one on.We've tried barriers but they do not help much.She's had to be prescribed steroid creams and antibiotics from the rash.At this point we are not sure if her body can handle to continually use it however not using it could be the difference of life or death.Since she's not the only one getting this rash we figured coming to you could help move dexcom along with going back to the original adhesive, provide a barrier that stops their product from touching skin or try something new.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11272464
• MDR Text Key: 230319988
• Report Number: MW5099160
• 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: 01/30/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/13/2021
• Device Model Number: G6
• Device Catalogue Number: G6
• Device Lot 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; Disability
• Patient Age: 12 YR
• Patient Weight: 70