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

Lot Number 5298430

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Rash (2033); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/30/2022

Event Type  Injury  

Event Description

Seven (7) days after applying dexcom g6 sensor (i am type 1 diabetic) i was forced to remove it because of the pain and foul smell coming from it.I removed it and revealed the same rash which i have been experiencing for the last 4 months (it is getting worse with each sensor applied).I keep reporting these rashes to dexcom as many others are experiencing the same (believe it is related to the adhesive which was changed in 2019) but no action has been taken to change the adhesive.I need to wear the sensors to prevent hypos, and having removed it i am now feeling very vulnerable.I don't want to reapply another because of the rash but am torn between wearing it and having the rash or not wearing it and experiencing hypos.Dexcom urgently needs to change the adhesive as so many of us are suffering (a dexcom rash (b)(6) group has been set up and more and more of us are getting the chemical burns).(b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 13425358
• MDR Text Key: 285072453
• Report Number: MW5107146
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Lot Number: 5298430
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CANDESARTAN; HAVE IMPLANTED PACEMAKER; INSULIN (NOVORAPID); SIMVASTATIN; VITAMIN D ; VITAMIN K2 (BUT THIS RASH OCCURRED INITIALLY BEFORE STARTING TO TAKE THESE)
• Patient Outcome(s): Disability
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White