MAUDE Adverse Event Report: Dexcom, Inc. Dexcom G7 15 Day Continuous Glucose Monitoring System

Model Number	9510-007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that physical damage occurred.Product was provided for investigation.An external visual inspection was performed and passed.Physical damage was not found within the investigation window.The allegation was not confirmed.However, a broken or detached needle or cannula was found in connection to the reported event.The probable cause of the broken or detached needle or cannula could not be determined.No injury or medical intervention was reported.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: Dexcom G7 15 Day Continuous Glucose Monitoring System
• Common Device Name: Continuous Glucose Monitor
• Manufacturer (Section D): Dexcom, Inc.; 6340 sequence dr.; san diego CA 92121
• Manufacturer (Section G): Dexcom, Inc.; 232 s dobson rd; mesa AZ 85202
• Manufacturer Contact: jaime chavez ; 6340 sequence dr.; san diego, CA 92121 ; +1(858)200-0200
• MDR Report Key: 50951760
• Report Number: 3004753838-2026-264355
• Device Sequence Number: 21439913
• Product Code: QBJ
• UDI-Device Identifier: 00386270004765
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• 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 Model Number: 9510-007
• Device Catalogue Number: STP-FT-012
• Device Lot Number: 1726166006
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/28/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 205 LB