MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	9500-160
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).E.1.Initial reporter state: (b)(6).
Event or Problem Description
Dexcom became aware that the user experienced a failure but did not receive the expected sensor failure alert on their g7 cgm application.Data was provided and an investigation was performed.The root cause was determined to be a coding issue.The g7 cgm application only detects that the session has ended, thus, it does not alert the user that the sensor has failed.No injury or medical intervention was reported.

• 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: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 23938780
• Report Number: 3004753838-2025-353232
• Device Sequence Number: 8955178
• Product Code: QBJ
• UDI-Device Identifier: 00386270003584
• UDI-Public: (01)00386270003584
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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 Expiration Date: 12/31/2025
• Device Model Number: 9500-160
• Device Catalogue Number: SW12300
• Device Lot Number: 1724188003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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: 30 YR
• Patient Sex: Female
• Patient Weight: 80 KG