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

Catalog Number	STK-SD-001
Medical Device Problem Code	Low Audible Alarm (1016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that an alert/notification settings issue occurred.Product was provided for investigation.An external visual inspection was performed and passed.Receiver charge and boot tests were performed and passed.Functional tests were performed and failed audio test.The receiver speaker manual test was performed and yields low sound.An alarm/alert manual test was performed and passed.The speaker/vibrator resistance was measured and passed.An internal visual inspection was performed and passed.The performance data was reviewed finding errors related to the complaint.The allegation was confirmed as low audio output via product.The probable cause was determined to be a defective speaker via product.No injury or medical intervention was reported.

• 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 ; 8582000200
• MDR Report Key: 24513222
• Report Number: 3004753838-2026-103990
• Device Sequence Number: 10244409
• Product Code: QBJ
• UDI-Device Identifier: 10386270000320
• UDI-Public: (01)10386270000320(11)180612(10)5239237
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/04/2026

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: STK-SD-001
• Device Lot Number: 5239237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HUMAPEN LUXURA HD.; LANTUS INSULIN PEN.
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 71 KG