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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Rash (2033)

Event Date 03/01/2022

Event Type  Injury  

Event Description

Caller stated that she has been using the dexcom g6 sensor since last year.Shortly after she started having rashes on the spot where the sensor is place in her body.She said she thought it may be the medication she takes or something she did wrong, so she stopped using the sensor and went back to using the needle to puncture her fingers.Later she found out on dexcom website that it was the sensor causing the rashes.She stated that dexcom changed the adhesive on the sensor that causes the reaction.

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 13677718
• MDR Text Key: 286770958
• Report Number: MW5107912
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American