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

Model Number DEXCOM G6 SENSOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/21/2021

Event Type  Injury  

Event Description

I have been using dexcom cgm for 3+ years and just recently started getting an allergic reaction to the adhesive.My endocrinologist indicated that there may have been a change in the adhesive and suggested that i report it.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 13385956
• MDR Text Key: 284712255
• Report Number: MW5107047
• Device Sequence Number: 1
• Product Code: MDS
• 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: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Model Number: DEXCOM G6 SENSOR
• Device Catalogue Number: REF STS-OE-003
• Device Lot Number: 7295681
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2022
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; CRESTOR ; INSULIN ASPARTATE ; METFORMIN ; VALSARTAN HYDROCHLOROTHIAZIDE
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White