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

Model Number G6 SENSOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 12/02/2020

Event Type  Injury  

Event Description

Itchy, painful rash; i started using the dexcom g6 cgm in (b)(6) 2020. It stays on your skin for 10 days, after that time you remove it and replace it with a new one on a different site on your body. Never had any skin issues with it. Starting in (b)(6) 2020, i noticed after 1-2 days of insertion, that the skin under the device started to itch. It was itching all the time, until i finally took it off after 10 days. After removal, i was shocked how horribly my skin looked. It was blotchy, red patches, in the exact shape of the dexcom's adhesive. It took several weeks until it was finally better and was not itchy any more. I don't know if dexcom changed the formula for their adhesive, but i never had a reaction the first 2 months. I now put a piece of tegaderm skin patch between my skin and the dexcom cgm, but it still irritates my skin tremendously. I really value the convenience of the cgm and how helpful it is with my diabetes control, but the itching is almost unbearable. Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE METER SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11553002
• MDR Text Key: 242062641
• Report Number: MW5100175
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00086270053038
• UDI-Public: 086270053038
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/12/2021
• Device Model Number: G6 SENSOR
• Device Catalogue Number: REF STS-OE-003
• Device Lot Number: 7282151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 03/22/2021 Patient Sequence Number: 1