MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CGM; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

Device Problems Patient-Device Incompatibility (2682); Device Ingredient or Reagent Problem (2910)

Patient Problems Purulent Discharge (1812); Erythema (1840); Nausea (1970); Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 06/11/2021

Event Type  Injury  

Event Description

In the past few months i have had an adverse reaction to the dexcom g6 sensor which i had used previously for 2 years with no issues.When contacting the company they admitted to changing the adhesive and a non-medical professional gave several tips for altering the device to help solve the problem such as adding a colloid bandage underneath this adhesive or a skin prep treatment.Each sensor leaves my skin with red, burn like reaction, raised bumps and scarred that last for over a 30 day period.This last sensor burned so bad after a few days it made me feel nauseous and i had to remove it.When i did it looked as if it had burned through several layers of skin as it was blistering and oozing pus.I facetimed my sister who is an rn with extensive er experience and she equated the reaction to the adhesive as heavy 2nd degree burn leaning toward 3rd degree burn and said that i needed to report it immediately.Fda safety report id#(b)(4).

• Brand Name: DEXCOM G6 CGM
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12086548
• MDR Text Key: 260548713
• Report Number: MW5102184
• Device Sequence Number: 1
• Product Code: QBJ
• 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: 06/24/2021
• 2 Devices were Involved in the Event: 1 2

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: 01/04/2022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 66