MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Blood Loss (2597)

Event Date 05/08/2020

Event Type  Injury  

Event Description

I use the dexcom g6 continuous glucose monitor, to track my blood sugar as a type 1 diabetic.Dexcom must have switched the adhesive they use cause all the sudden i'm getting a bleeding rash after 2 days of wearing it.Before i could wear it 10 days with no effects on my skin.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10051367
• MDR Text Key: 190954825
• Report Number: MW5094464
• Device Sequence Number: 1
• Product Code: QDK
• Combination Product (y/n): Y
• 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: 05/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/24/2023
• Device Model Number: G6
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR