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

Model Number G6

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/25/2021

Event Type  Injury  

Event Description

Ever since dexcom switched adhesive to make the sensor last 10 days, i have had severe reactions to the adhesive resulting in 2nd degree burns.Contacted dexcom with no resolution.Dexcom gave tips (basically buying separate products) to make the g6 usable.They were not the least bit concerned.The people that use this product are diabetics and an open wound could result in sepsis or worse.This is not acceptable.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11900798
• MDR Text Key: 253558604
• Report Number: MW5101606
• 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: 05/25/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G6
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 91