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

Lot Number 7278826

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

Patient Problems Rash (2033); Burning Sensation (2146)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Patient called to report an adverse reaction to his dexcom g6 sensor.Patient stated that the sensors are supposed to last him 10 days, but halfway through that he gets a terrible burning rash and has to take the sensor off early.Patient stated dexcom has changed the adhesive, and read on-line that many other people are having the same issue he is.

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10829574
• MDR Text Key: 216220458
• Report Number: MW5097815
• 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: 11/10/2020

1 Device was Involved in the Event

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 Lot Number: 7278826
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR