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

Model Number G6

Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Peeling (1999); Skin Irritation (2076); Discharge (2225); Discomfort (2330)

Event Date 02/01/2020

Event Type  Injury  

Event Description

Caller is reporting on the dexcom g6 10 days sensors.She has been using the device for years and follows the instructions on applying the device.She alleges that after 5 hours of replacing a sensor, she experienced an irritation which was unbearable and the area began to itch terribly this caused her to scratch the area due to the discomfort.The area became reddened and was weeping, making the area wet and causing the device to fall off.This leaves her skin peeled, irritated and infected.Caller states "there is a rash making the area feel like sand paper".Caller advised she has notified the manufacturer and has emailed pictures of the scarring and all they do is replace sensors and recommend using skin preps you have to buy for (b)(6).Caller is on (b)(6) and can not afford any extra expense.She states "my arm got so infected i missed 3 days of work".Caller wants the fda to look into this as many other users are suffering.She is part of a (b)(6) group who are looking into pursuing a class action lawsuit against the manufacturer.Caller advised the scarring on her body is terrible and its affecting her self confidence as she is hiding her body from her partner and covering up with long sleeves in hot weather.She states she is disfigured from using the device.Caller estimates this issue has occurred over 30 times beginning (b)(6) of this year and something needs to be done.

• Brand Name: DEXCOM G6 SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10390370
• MDR Text Key: 202608176
• Report Number: MW5095993
• 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: Patient
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G6
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 37 YR
• Patient Weight: 75