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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Irritation (2076); Swelling (2091); Reaction (2414)

Event Date 08/28/2020

Event Type  Injury  

Event Description

New versions (tried both new versions) of dexcom sensor adhesive causes a severe skin reaction where the skin blisters and peels.Previous version is not available per dexcom customer service.Please ask the dexcom to switch back to the previous version of the adhesive.Fda safety report id # (b)(4).

• Brand Name: DEXCOM SENSOR (ADHESIVE)
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10482221
• MDR Text Key: 205509125
• Report Number: MW5096369
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 08/28/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other