MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

Catalog Number STS-OR-003

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Fluid Discharge (2686); Blister (4537)

Event Date 11/23/2020

Event Type  Injury  

Event Description

I was using my dexcom g6 sensor for my cgm system, which i had been using for months.After a day or two of insertion i began having itchy, weeping blisters under the site.I had to find a barrier method to help prevent the adhesive from touching my skin, and until i found one that worked they have left scars.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11272512
• MDR Text Key: 230317647
• Report Number: MW5099164
• Device Sequence Number: 2
• Product Code: QBJ
• 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: 01/30/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: STS-OR-003
• Device Lot Number: 7279817
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 26 YR
• Patient Weight: 82