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

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Local Reaction (2035); Skin Irritation (2076); Blood Loss (2597)

Event Date 05/29/2020

Event Type  Injury  

Event Description

Scarring, blistering skin; i have been using the dexcom g6 cgm for months.The last two sensors have left me with what appear to be terrible allergic reactions.My skin starts itching almost immediately upon insertion even though i'm following all of the recommended "sensitive skin" protocols from their website.Upon removing the sensor, my skin is bleeding, blistered, and shows a nasty itchy rash that takes weeks to heal.I've called dexcom about the issue but am redirected to my doctor.My doctor's response is that they've been getting a huge influx in complaints from patients with this same skin reaction.Dexcom claims there is no issue with the product on their end and they aren't aware of any issues.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10114358
• MDR Text Key: 194040858
• Report Number: MW5094808
• Device Sequence Number: 2
• Product Code: MDS
• 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: 05/30/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G6
• Device Lot Number: 5270207
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 64