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

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Itching Sensation (1943); Skin Irritation (2076); Fluid Discharge (2686)

Event Date 08/15/2020

Event Type  Injury  

Event Description

Dexcom introduced new adhesive without letting any customers know and now i have been suffering from severe allergic reaction including itching for the 10 days of the life of the sensor and it continues for 10 or more days after.I also have red bumps filled with pus and liquid inside which is causing infection.They are not helping with any solution and being (b)(6) months pregnant, my stomach looks like i am having some skin rash on my stomach.I have tried the films they recommended but nothing happening.If they would have sent samples to test earlier before launching, we would have at least had the chance to try out the new adhesive.Fda safety report id# (b)(4).

• Brand Name: SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10425245
• MDR Text Key: 203682489
• Report Number: MW5096126
• 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: 08/15/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: G6
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR