MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR PATCH; TAPE AND BANDAGE, ADHESIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Blister (4537)

Event Date 06/01/2023

Event Type  Injury  

Event Description

I started using the g6 dexcom in march after using libre for years.Recently, i've had skin allergic reactions to the new adhesive that dexcom switched to without fda approval.I have redness, blistery patches, and itching around and under the adhesive on each patch.

• Brand Name: DEXCOM G6 SENSOR PATCH
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 17108375
• MDR Text Key: 317125856
• Report Number: MW5118318
• Device Sequence Number: 1
• Product Code: KGX
• 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: 06/06/2023

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2023
• Patient Sequence Number: 1
• Treatment: HUMALOG, INSULIN PUMP, DEXCOM G6.; PRENATAL, VITAMIN D.
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White