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

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Skin Discoloration (2074)

Event Date 07/04/2020

Event Type  Injury  

Event Description

My daughter is a type one diabetic and has used a dexcom g6 cgm since (b)(6) 2019.Since around (b)(6) 2020 we have noticed that after removing the dexcom after ten days of wear she's left with a red rash and burn marks on her skin.She also complains of itching and pain at the site while wearing the dexcom g6.My daughter did not originally have this issue with the dexcom g6.She's not allergic to any tape or adhesives that we're aware of.We apply an overlay adhesive patch over the dexcom g6 and she's had zero reaction to the adhesive in that product.I have been told by dexcom that they had a change in the adhesive they use for the dexcom g6.I believe that this is why my daughter, along with others in the type one diabetes community, are having a reaction to wearing this product.I've included images of my daughter's abdomen after removing the dexcom g6 after ten days of wear.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: 10250184
• MDR Text Key: 198341961
• Report Number: MW5095433
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000255
• UDI-Public: (01)00386270000255
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/17/2021
• Device Model Number: G6
• Device Catalogue Number: 950045
• Device Lot Number: 7273630
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 28