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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Local Reaction (2035); Impaired Healing (2378)

Event Date 04/11/2021

Event Type  Injury  

Event Description

Dexcom g6 sensors are causing intense skin reaction and persistent rash.Because these sensor should only be used in certain parts of the body i've had to place sensors on my skin that is still healing from a previous rash.I've been using dexcom for many years and just recently they are causing this bad reaction.There are now (b)(6) groups dedicated to people having these adverse reactions.Dexcom customer support offers no explanation and cannot tell me how to resolve this issue.Please investigate if they've started using a new adhesive that is not as safe.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: 11663949
• MDR Text Key: 245565376
• Report Number: MW5100757
• Device Sequence Number: 1
• Product Code: MDS
• 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: 04/11/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 86