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

Device Problems Patient-Device Incompatibility (2682); Device Ingredient or Reagent Problem (2910)

Patient Problems Rash (2033); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 06/01/2021

Event Type  Injury  

Event Description

Patient called to report an adverse reaction to her dexcom g6 sensors.Patient stated she's used 2 sensors over the last two months that have caused her to have a horrible skin reaction to the adhesive.Patient stated that under the sensor her skin has a red, raised, blistering rash that is still there a month later.Patient stated she has stopped using the dexcom sensors.Patient said she would like to see dexcom make some changes to their adhesive as she knows many other people are experiencing the same problem.

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12173305
• MDR Text Key: 261953367
• Report Number: MW5102555
• Device Sequence Number: 2
• 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: 07/14/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• 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 Outcome(s): Other
• Patient Age: 23 YR