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

Device Problem Product Quality Problem (1506)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Urticaria (2278); Reaction (2414)

Event Date 04/30/2020

Event Type  Injury  

Event Description

I had a negative skin reaction to the adhesive on my sensor of my dexcom g6 constant glucose monitor.The skin on my site was infected and inflamed.As a result hives spread on my body.My doctor saw the site and prescribed me steroids as a result.It took two weeks for my skin to recover.Doctors appointment to look at site and prescribe medication to help.Fda safety report id# (b)(4).

• Brand Name: G6 CONSTANT GLUCOSE MONITOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10108828
• MDR Text Key: 193637494
• Report Number: MW5094780
• Device Sequence Number: 1
• 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: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 32 YR
• Patient Weight: 75