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

Model Number G6

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Scar Tissue (2060); Skin Disorders (4543); Skin Inflammation/ Irritation (4545)

Event Date 01/01/2021

Event Type  Injury  

Event Description

"scarring to the skin" when the sensor is removed every 10 days from the abdomen area, it leaves a tremendous irritation where the adhesive holds the sensor in place.It takes 4-6 weeks for each area to heal, so after 4-6 weeks a patients entire stomach area is filled with terrible irritation, blotches, rough skin, etc.According to various blogs for diabetics, there are over 13,000 people with this problem.Technology is good when the machine works but many times breaks down.Biggest problem is that the skin is destroyed when the sensor is removed and changed.Pictures have been taken over a 6 moth period.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12662357
• MDR Text Key: 277684149
• Report Number: MW5104732
• 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: 10/14/2021

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: No Information
• Device Model Number: G6
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 82