MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINIOUS GLUCOSE SENSOR; SENSOR, GLUCOSE, INVASIVE

Model Number STS-0M-003

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2022

Event Type  malfunction  

Event Description

Dexcom g6 sensor device failed to release requiring forced removal of the device.The occurred with 5 different devices.The patient is on the insulin pump and has the closed-loop feedback device engaged.The lack of the glucose sensor input requires to use of manual entry of blood sugars into the pump and inactivates the close loop function.The dexcom g-6 device is a very effective monitor of continuous glucose measurement in patients with diabetes.Many patients become dependent on input for these sensors for the management of their diabetes.Dexcom has manufactured a series of glucose sensors over the use and i have used all of them within my practice.There has been a little difficulty with the prior glucose sensor devices.But with the introduction of the dexcom g6 device i have noticed, there is a significant failure rate for the device, the device is placed on the skin and attached by a sticky surface, and a button is pushed to apply the sensor into the skin.The sensor will fail to release and result in an applicator attached to the skin which will be forcefully removed to release and to be activated.This requires the removal of the device because it failed and the replacement of a new device.But on occasion, i have experienced failure of 4 to 5 devices in a row as pointed out in this document, in looking at the fda database i did not see any reports about this being a problem.In my experience upward to 40% of the device fail which increases the frustration of the patient and interferes with the management of the patient diabetes control.This is not a life threatening issue but is an inconvenience to the patients and the physician who assist in managing these patients.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 CONTINIOUS GLUCOSE SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.; san diego CA 92121
• MDR Report Key: 13549591
• MDR Text Key: 285840655
• Report Number: MW5107543
• 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: Physician
• Type of Report: Initial
• Report Date: 02/14/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2023
• Device Model Number: STS-0M-003
• Device Lot Number: 5294673
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TANDEM INSULIN PUMP-(B)(6) 2016-(B)(6) 2022
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White