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

Model Number G6

Device Problem Product Quality Problem (1506)

Patient Problems Scarring (2061); Fluid Discharge (2686)

Event Date 09/04/2020

Event Type  Injury  

Event Description

Had to remove a dexcom g6 sensor because it here was puss leaking out.I have scars on every insertion site.It's just getting worse.The scars heal in about 2 months.Despite using barrier film this was my worst reaction.I love my dexcom.It has saved my life.But it is killing my skin since they changed their adhesive.I called them tonight and they told me to contact my physician, but they would not file an adverse event report; ugh.Fda safety report id# (b)(4).

• Brand Name: DEXCOM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10513835
• MDR Text Key: 206521841
• Report Number: MW5096499
• 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: 09/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 66