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

Lot Number 5275341

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Fluid Discharge (2686)

Event Date 09/02/2020

Event Type  Injury  

Event Description

The harmful product is the g6 blood glucose monitoring sensor patch produced by dexcom.I have been using this system for years without any problems at all.Suddenly the trouble began with one sensor about 6 weeks ago and every sensor i have applied since then.After a couple of days my skin under the adhesive patch begins to itch and then ooze a foul liquid.When i remove the patch i have a severe oozing rash which takes weeks to heal.I have tried using barrier creams prior to applying the patch, but they have not helped.I am reliant on this cgm for the management of my diabetes and am desperate for a solution.I have numerous photos of the condition of my skin when the adhesive patches have been removed.Fda safety report id# (b)(4).

• Brand Name: G6 CONTINUOUS BLOOD GLUCOSE MONITORING
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10501303
• MDR Text Key: 206143004
• Report Number: MW5096452
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/18/2021
• Device Lot Number: 5275341
• 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): Other
• Patient Age: 52 YR
• Patient Weight: 91