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

Model Number G6

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Itching Sensation (1943); Rash (2033); Blister (4537)

Event Date 05/03/2020

Event Type  Injury  

Event Description

I have used a dexcom cgm for over 7 years.I have never had a single problem with the adhesive causing reactions.This time (and four additional times, also reporting to you) the adhesive caused a rash so bad i blistered and bled.Upon calling dexcom, they said they had a change in formula and suggested i purchase a barrier.It takes multiple layers of barriers to remove the itching and even then, it's not 100%.The rash at first was so bad it leaked off the adhesive and made the device fall off.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: 11019348
• MDR Text Key: 222121765
• Report Number: MW5098407
• Device Sequence Number: 1
• 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: 12/13/2020
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G6
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR