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

Model Number G6

Device Problems Break (1069); Product Quality Problem (1506); Defective Device (2588)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/05/2020

Event Type  Injury  

Event Description

Dexcom g6 sensor wire broke off into my abdomen.This is a continuous blood glucose monitoring system.The "sensor" is a wire which is injected into the patient by a hand held gun like device, and the sensor is attached to two holders that are supposed to keep it mounted into a plastic container.Between the container and the body is an adhesive bandage.So the container sits on top of the bandage and when the trigger is depressed, the gun injects the wire into the abdomen.That part is painless, which is good.The sensor wire is fairly fine in diameter and seems metallic.The sensor wire somehow reads interstitial glucose levels.Into the plastic container the patient inserts a 'transmitter' which apparently collects a signal from the sensor and then transmits it to a receiver.I am told the wire is silver-platinum with polymer membranes.The dexcom rep could not tell me what the "polymer membranes" are or the risks of leaving the wire in the body indefinitely dexcom is very good about replacing a broken sensor that does not last for 10 days, but the problem from a design standpoint is that i do not believe a single one of the sensors has lasted 10 days, they always break off prematurely.This normally occurs if the sensor contraption is bumped or rubbed by a waistband.Wearing this last one the placement was a few inches below the navel, and i asked dexcom where this should be placed to avoid these things breaking off within my abdomen, i follow their instructions.I think this product is defectively designed in terms of the wire breaking off.Tonight it broke off simply from pressure from the waistband of my pants while i was sitting in a chair.The wire is very fine, so i don't know if it will travel.I told the dexcom rep that i would have an x-ray to see if it might be located and extracted at the emergency room.The dexcom system is conceptually good, and it is very helpful when it is working in provision of updated blood glucose readings, except for the issue with the wire breaking off and being irretrievable by the patient.It stops giving readings when the wire breaks and then sounds an alarm in combination with the receiver providing a message alerting, it is not receiving readings so that the patient can inspect the installation site, and if the wire has broken go to get an xray and possibly have it extracted.I feel there is a simple design change which could be implemented to better secure the wire for removal should it break or detach from the anchoring.The fda may not get many reports of this but that may be because patients may not perceive a risk in leaving the wire floating in their body.Dexcom needs to be ordered to either provide a new design that is helpful to the patient in retrieving the wire without an x-ray or possible medical procedure to dig it out.Certainly, over time leaving foreign bodies in the abdomen must present risks the least of which may be infection and of more concern the potential of serious injury should it travel.There should also be a black box warning regarding installation and a procedure to inspect each sensor as removed and report breakage so that the actual frequency of the product failure can be better known and to determine if the product should be withdrawn from the market.I cannot believe that many other patients have not had similar problems.One way to get an idea is to ask dexcom for the number of sensors replaced, and drill it down to per patient and per patient frequency.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10514087
• MDR Text Key: 206528398
• Report Number: MW5096508
• Device Sequence Number: 1
• 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: 09/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/29/2021
• Device Model Number: G6
• Device Catalogue Number: 9500-45
• Device Lot Number: 7277577
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 118