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

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Erythema (1840); Itching Sensation (1943); Swelling (2091); Discharge (2225); Discomfort (2330); Reaction (2414)

Event Date 10/01/2020

Event Type  Injury  

Event Description

Rash / wound; i have been using my dexcom g6 cgm for almost 2 years without any problem.Over the past 2 months and around 6 sensors i have experienced a severe reaction from my sensors.They are designed to last 10 days but i was only making it 6-8 days.While in use the site would become so itchy, it was uncomfortable to wear.The itching then would loosen the adhesive on the edge of the site causing early failure.Then once removed i would have a large sore the exact size of the adhesive patch.The wound would be red, raised, and often ooze.This would last a few days.The oozing would stop but the site remains red, dry, and itchy for weeks.I have attempted to use barrier wipes and flonase to prevent the reaction but so far nothing has worked.I have always used the approved site for the cgm of my abdomen but now have so many bad areas i have had to switch to my arm.This product has changed my life in how controlled my blood sugars have been while wearing them.I would give anything to go back go wearing them comfortably.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10748498
• MDR Text Key: 213881097
• Report Number: MW5097506
• Device Sequence Number: 3
• 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: 10/26/2020
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 84