MAUDE Adverse Event Report: Dexcom, Inc. Dexcom G7 Continuous Glucose Monitoring System

Catalog Number	SW12300
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an alert/notification settings issue occurred.It was indicated that the patient was using an unsupported operating system, which is misuse of the device.Performance data was reviewed.An alert issue was not found within the investigation window.The allegation was undetermined.However, signal loss over 1 hour was found in in connection to the reported allegation.The probable cause of the signal loss was the transmitter and app were unable to establish a connection.No injury or medical intervention was reported.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: Dexcom G7 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: 50947319
• Report Number: 3004753838-2026-263658
• Device Sequence Number: 13374895
• Product Code: QBJ
• UDI-Device Identifier: 00386270001863
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213919
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: SW12300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 205 LB