MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

Catalog Number	STS-OM-001
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that start new sensor occurred.The sensor was inserted into the abdomen on (b)(6) 2025.Data was evaluated and the allegation was confirmed as an early sensor expiration was confirmed.The probable cause was determined to be early sensor expiration.The probable cause of the early sensor expiration could not be determined.The reported event of a start new sensor is reportable based on the finding of an early sensor expiration.No injury or medical intervention was reported.
Additional Manufacturer Narrative
(b)(4).

• 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: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 23444564
• Report Number: 3004753838-2025-308269
• Device Sequence Number: 18161138
• Product Code: QBJ
• UDI-Device Identifier: 80386270000251
• UDI-Public: (01)80386270000251
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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 Catalogue Number: STS-OM-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INSULET OMNIPOD5.
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 62 KG