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

Model Number DEXCOM G6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Itching Sensation (1943); Skin Irritation (2076); Discomfort (2330)

Event Date 10/26/2020

Event Type  Injury  

Event Description

I am type 1 diabetic using dexcom g6 sensor in conjunction with tandem ii pump.I have used the dexcom g6 and previous versions for many years.Recently, i had a bad skin reaction (intense itching, irritation, marks that won't fade).The g6 is very expensive and is worn for 10 days.I am supplied by insurance with an exact amount and cannot waste these.I ended up having to remove the sensor before the 10 days due to extreme discomfort.After calling dexcom, they admitted to having made changes in the adhesive recently, which is contributing to many customers having extreme skin reactions.Dexcom admits that this is a very bad situation.This is very frightening for a diabetic because many of us wear the sensor in conjunction with our pumps in order to control our blood sugars.I have had the allergic reaction occur with subsequent sensors which means that i have to remove them before the 10 day use.My insurance is not going to cover these replacements.Currently, dexcom is admitting that they have no eta on when this will get fixed.They have offered me solutions such as to apply a barrier between my skin and the sensor.This is not a solution and only works minimally.I can vouch that there are many diabetics like myself who are panicking at this sudden situation.It's not a matter of simply switching to another device; we are literally attached to our pumps (which work in conjunction with the sensors).I can't just switch to another sensor.If i'm correct, the market offers us only two choices of sensors, one of which does not work with my new tandem control iq pump.I implore you to look into this situation.Not only am i left with red irritating itchy skin that leaves permanent marks, dexcom told me that the irritation can actually impact the blood sugar readings that the sensor provides.This is dangerous.I am willing to be contacted: (b)(6).Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITOR - SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM INC
• MDR Report Key: 10837669
• MDR Text Key: 216411092
• Report Number: MW5097861
• Device Sequence Number: 1
• Product Code: MDS
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/09/2021
• Device Model Number: DEXCOM G6
• Device Lot Number: 5274697
• 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
• Patient Age: 65 YR
• Patient Weight: 57