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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction to Medicinal Component of Device (4574)

Event Date 02/16/2022

Event Type  Injury  

Event Description

Bad reaction to adhesive from the dexcom sensor.This is the third and worse time i've had the reaction after trying different ways to prevent the reaction.Fda safety report id # (b)(4).

Event Description

Bad reaction to adhesive from the dexcom sensor.This is the third and worse time i've had the reaction after trying different ways to prevent the reaction.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: 13562818
• MDR Text Key: 285957526
• Report Number: MW5107581
• 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: 02/16/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: DEXCOM G6; METFORMIN; TOUJEO
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic
• Patient Race: White