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

Model Number DEXCOM G6 SENSOR

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Tears (2516)

Event Date 01/31/2021

Event Type  Injury  

Event Description

I am diabetic and i use dexcom g6 sensors to monitor my blood sugar.For the last lot of 3 sensors that i used (lot no.7277117; ref no.Sts-gs-003; fab.2020-07-15; exp.2021-07-15) i faced severe skin allergies/ skin damage for which i will need medical attention from a dermatologist.Such symptoms have not occurred in the past when using different batches of sensors.I mention that i do not have any allergies or other skin problems.Please check if the manufacturer has changed the formula of the patch gluing solution.This might cause side effects when using dexcom sensors.(sensor + transmitter - connected to the smart phone).Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11272765
• MDR Text Key: 230533024
• Report Number: MW5099180
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 50386270000250
• UDI-Public: (01)50386270000250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/31/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/15/2021
• Device Model Number: DEXCOM G6 SENSOR
• Device Catalogue Number: REF STS-GS-003
• Device Lot Number: 7277117
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 62