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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Caustic/Chemical Burns (2549); Swelling/ Edema (4577)

Event Date 12/20/2020

Event Type  Injury  

Event Description

Chemical burn and blisters; this involves a dexcom g6 continuous glucose monitoring system.The problem is the adhesive on the sensor.I have tried numerous attempts at mediating the adhesive reaction including: liquid barrier films, flonase spray on skin, tegaderm film, leaving the tabs on the adhesive and attaching with large tegaderm film overall.I used the dexcom g4 with no problem but apparently the adhesive has been reformulated.There is an entire (b)(6) group of people having reactions to the adhesive on the g6.There is really no test for this as it is a skin reaction 2 an adhesive.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11421891
• MDR Text Key: 238392083
• Report Number: MW5099807
• Device Sequence Number: 2
• 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: 03/02/2021
• 2 Devices were Involved in the Event: 1 2

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 68