MAUDE Adverse Event Report: Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring System

Catalog Number	STT-OE-002
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	09/16/2026
Type of Reportable Event	Serious Injury

• Brand Name: Dexcom G6 Continuous Glucose Monitoring System
• Common Device Name: Continuous Glucose Monitor
• Manufacturer (Section D): Dexcom, Inc.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: jaime chavez ; 6340 sequence dr.; san diego, CA 92121 ; +1(858)200-0200
• MDR Report Key: 50952044
• Report Number: 3004753838-2026-264409
• Device Sequence Number: 10446812
• Product Code: QBJ
• UDI-Device Identifier: 00386270001771
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: DEN170088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: STT-OE-002
• Device Lot Number: 22001587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 103 LB