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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Fluid Discharge (2686); Skin Burning Sensation (4540)

Event Date 02/20/2021

Event Type  Injury  

Event Description

Itchy rash, painful lesions; i've been using the dexcom for quite a while.The last few times i applied the sensor i began to itch and burn at the site of application.I removed the sensor and found raised, oozing red bumps beneath the sensor where the adhesive pad contacted my skin.Fda safety report id# (b)(4).

• Brand Name: SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11444430
• MDR Text Key: 238860580
• Report Number: MW5099847
• Device Sequence Number: 2
• 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: 03/04/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 86