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

Model Number G6

Device Problems Output Problem (3005); Physical Resistance/Sticking (4012)

Patient Problems Hemorrhage/Bleeding (1888); Skin Discoloration (2074)

Event Date 08/25/2020

Event Type  Injury  

Event Description

I have had several calls into dexcom that their sensors that are marketed to last 10 are only last on average 7-8 days.I have had several sensors replaced over the years.In addition, the device that launches the sensor onto the body to release the sensor did not release when the device was pushed, and had to pull until the unit from my body that caused it to bleed and area around was all black and blue.I have photos for proof of this happening.Apply new sensors every 10 days; applied to the skin.Reason for use: diabetic and helps in keeping track of blood sugar read outs.I have been using the dexcom g6 for the last few years replacing sensors every 10 days.

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10553235
• MDR Text Key: 207721233
• Report Number: MW5096739
• Device Sequence Number: 2
• 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: 09/01/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G6
• Device Lot Number: 7273627
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 64