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

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Peeling (1999); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545)

Event Date 11/02/2021

Event Type  Injury  

Event Description

Severe skin irritation at sensor site.During the 10 day wear period the skin underneath the sensor grew itchy and hard to touch in some points.Upon removal skin was dark purple, peeled up a lot of skin causing bleeding.There was also yellow oozing puss and residue.The residue was also on the sensor patch when removed.In the following days site remained irritated, itchy, and bruised.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12787665
• MDR Text Key: 280750362
• Report Number: MW5105241
• 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: 11/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Model Number: G6
• Device Lot Number: 7291521
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2021
• Patient Sequence Number: 1
• Treatment: DEXCOM G6 TANDEM T:SLIM X2 ; HUMALOG
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White