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

Catalog Number STS-OR-003

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Defective Device (2588)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/17/2020

Event Type  Injury  

Event Description

I use a dexcom g6 system to monitor my bg for diabetes.Upon recent application of the g6 sensor, the sensor did not release from the applicator.In order to release the applicator from the sensor and then remove from the insertion site, i had to have a family member pry it out using a flat head screwdriver.At that time, it became apparent that part of the sensor that houses the insertion needle had broken off from the rest of the unit and was bent.Upon further inspection of the insertion site, part of the wire that is inserted into the skin had broken off and remained in the arm.Unfortunately, my son is also a type 1 diabetic and just started using the g6 system as well.He has had 4 such similar experiences since he started using the system 2 months ago, leading to great delays in getting replacements and subsequently reverting to using finger sticks for managing his diabetes.There has been no update from the dexcom team regarding these defective products and a pending solution.An additional note: all of the defective supplies were sent by (b)(4).Before changing insurance providers through work in may, all of my supplies came directly from dexcom.In nearly 9 months of ordering directly from dexcom, there were no such instances of defective devices.Fda safety report id# (b)(4).

• Brand Name: SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10436222
• MDR Text Key: 204189837
• Report Number: MW5096162
• Device Sequence Number: 2
• 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: Patient
• Type of Report: Initial
• Report Date: 08/15/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: STS-OR-003
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 68