MAUDE Adverse Event Report: UNKNOWN GLUCOSE SENSOR BARRIER UNDERLAY; TAPE AND BANDAGE, ADHESIVE

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Type  Injury  

Event Description

I have had numerous issues with dexcom's g7 continuous glucose monitors.I am forced to use dexcom products because my insurance will not cover any other brand entirely.The adhesive that dexcom uses has caused me several rashes.After reaching out to dexcom, they advised utilizing a skin prep wipe.I tried that but i continued to get a rash.Then they and my doctor recommended using a barrier underlay.That worked a few times, except the device failed early, a few days ahead of the 10-day wear.It also has very bad connection issues with the phone app, and i continuously get sensor reading errors throughout the day.The underlay has also made it difficult to properly deploy the device.I inserted one just now and it did not even finish warming up before it failed.I have visited forums where people share similar experiences with dexcom g6 and g7.In addition, dexcom limits the number of sensors they replace within a certain period, forcing people to pay out of pocket because their device is faulty! and if the one you paid out of pocket for also malfunctions, then tough luck! cgms (continuous glucose monitors) are a very important device for diabetics, and insurance has tied our hands in covering only this brand that has had serious issues for many people.Please intervene and protect american patients from this very frustrating situation.Reference reports: mw5149496, mw5149497.

• Brand Name: GLUCOSE SENSOR BARRIER UNDERLAY
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18392272
• MDR Text Key: 331440226
• Report Number: MW5149498
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/13/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2023
• Patient Sequence Number: 1
• Treatment: G7 CONTINUOUS GLUCOSE MONITOR SENSOR.; G7 MOBILE APP.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian