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

Model Number G6 SENSOR (STS-OR-003)

Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 08/18/2021

Event Type  malfunction  

Event Description

I use the dexcom g6 cgm system; 4 out of 6 sensors from lot 7279782 and 1 out of 2 sensors from lot 7283346 that i have attempted to insert have failed to detach from the applicator.When the applicator fails to detach, the insertion needle remains embedded in the skin until the adhesive is removed.This has caused pain, bleeding, and skin irritation at the insertion site.The product must be removed and disposed of if it fails to deploy.The strong adhesive makes the sensor difficult to remove, prolonging the time where the applicator needle remains painfully embedded in the body.Dexcom has replaced the failed sensors, but has refused to replace or recall unopened sensors from the same batch, despite admitting that a known manufacturing defect causes the sensors to fail to deploy.Repeated sensor insertion failures have caused me physical and mental trauma, and have resulted in anxiety and reluctance to use the medically prescribed product.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12353653
• MDR Text Key: 267856399
• Report Number: MW5103382
• Device Sequence Number: 5
• 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: 08/18/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/15/2021
• Device Model Number: G6 SENSOR (STS-OR-003)
• Device Lot Number: 7283346
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 75