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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Irritation (2076)

Event Date 06/10/2020

Event Type  Injury  

Event Description

I have been wearing the dexcom g6 cgm since january of this year without an issue.Until i rec'd my second order of the cgm sensors.Since the end of may i have experienced itching upon placing the g6 sensor on my stomach from the adhesive.Upon removing the cgm 10 days later i have a blistering 2x3 inch rash.I checked the faqs for experiencing a bad reaction on the dexcom site and as a preventative applied an iv 3000 barrier film on my skin and then placed a new sensor on that.However i had to remove the second sensor earlier than 10 days and when i did i had another red rash 2x3 rash.I called dexcom today to report this and the customer support person was a terrible listener as i started by telling him my bad sensor adhesive experience and that i had been seen by my endocrinologist (who could not believe the blistering rash i have), have been placed on both an antibiotic and betamethasone valer 0.1% ointm ointment cream.I told the customer service rep that i read the faqs on the dexcom site.But as is typical, he was not listening, he directed me to the faq document and to my endocrinologist.Finally i got him to understand that i was calling to report my adverse reaction to the sensor adhesive.He took the lot number from the sensor box and opened a case.I pressed him on if dexcom had changed the adhesive and he said yes there had been a slight change recently.I then pressed him if my feedback would be shared with the product team and he responded that he had opened a case but would not say who reviews the cases or how often.This is really frustrating because i had no issues until the last 2 cgm sensors.(b)(4).

• Brand Name: SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10179855
• MDR Text Key: 196151602
• Report Number: MW5095134
• Device Sequence Number: 3
• 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: 06/18/2020
• 3 Devices were Involved in the Event: 1 2 3

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 55