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

Device Problem Product Quality Problem (1506)

Patient Problems Peeling (1999); Rash (2033)

Event Date 04/01/2021

Event Type  Injury  

Event Description

Severe rash and skin peeling from dexcom adhesion site.The rash and skin peeling has occurred on last 4 insertions.Reported to dexcom.They have not followed up.I have been using dexcom for years without any rash.I have been told they changed the adhesive and many people are having severe skin issues.Fda safety report id # (b)(4).

• Brand Name: SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11663976
• MDR Text Key: 245576364
• Report Number: MW5100759
• Device Sequence Number: 4
• 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: 04/11/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• 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: 64 YR
• Patient Weight: 76