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

Lot Number 5280542

Device Problem Product Quality Problem (1506)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Reaction (2414)

Event Date 01/19/2021

Event Type  Injury  

Event Description

When using my dexcom g6, the past 3 sensors have left very painful and itchy chemical burn like rashes.Sensors are meant to be worn for 10 days and in doing so, severe reactions are occurring.I have no history or sensitive skin or allergies and have not had this issue in the past.I believe dexcom made a change to the chemical make up of their product that is causing severe reactions in already immunocompromised patients.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11214203
• MDR Text Key: 228442913
• Report Number: MW5098949
• 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: 01/20/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2021
• Device Lot Number: 5280542
• 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: 31 YR
• Patient Weight: 54