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

Model Number G6 CGM SENSORS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Burn(s) (1757); Itching Sensation (1943); Scarring (2061)

Event Date 12/20/2020

Event Type  Injury  

Event Description

Started using dexcom g6 cgm around (b)(6) 2019 without any problems.Around (b)(6) 2020: started having severe itching while using dexcom g6 adhesive patch.Once patch removed, skin would appear "burned".Would have to use silvadene cream 3-4 times a day until sight was healed, but scarring would persist and take longer to heal.Reached out to company and was informed that the product was changed in early 2020 and now contained a new "hypoallergenic" adhesive product.Instructed me to attempt various barrier methods, which i did, without success.Stopped using product for several months.Attempted again to use product in dec 2020 with barrier adhesive, resulting in same side effect.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: 11222716
• MDR Text Key: 228683716
• Report Number: MW5098969
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 50386270000250
• UDI-Public: 50386270000250
• Combination Product (y/n): Y
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/27/2021
• Device Model Number: G6 CGM SENSORS
• Device Catalogue Number: STS-OR-003
• Device Lot Number: 5274353
• 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): Other
• Patient Age: 55 YR
• Patient Weight: 74