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

Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problems Rash (2033); Skin Irritation (2076); Blood Loss (2597); Fluid Discharge (2686)

Event Date 05/20/2020

Event Type  malfunction  

Event Description

I have used the dexcom cgm for a while since the g5 model.I am currently using the g6 system.The last few sensors i have inserted have a different adhesive that causes severe rashes under the adhesive part of the device.This rash starts almost immediately and causes oozing, bleeding welts that eventually scab over and cause the device to fall off before the sensor expires.Even after removing the device the rash persists for 2 weeks or sometimes longer even with care.Fda safety report id# (b)(4).

• Brand Name: DEXCOM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10148240
• MDR Text Key: 195155511
• Report Number: MW5094963
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• 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: 32 YR
• Patient Weight: 73