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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Skin Irritation (2076)

Event Date 08/29/2020

Event Type  Injury  

Event Description

Reporter stated she is diabetic and using dexcom g6 glucose monitor.Lately she was experiencing reactions like itching at the 7th day of wearing the sensor when it is supposed to last for 10 days.She said she was having terrible rashes that are weeping, open wound, welt and incredibly painful.She said she normally does not have any reaction to anything and does not have a sensitive skin.She also said since she is diabetic, so any kind of wounds take longer to heal.She had two bad experiences with these sensors.The first time she did not associate it with the sensor.When it happened the second time, she knew that she was having reactions from the sensor.

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10477775
• MDR Text Key: 205319386
• Report Number: MW5096365
• 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: 08/31/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 58