MAUDE Adverse Event Report: Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring System

Model Number	MT24078
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
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 the vibrator test failed.A manual alarm/alert test was performed and failed.The vibrator motor resistance was measured and failed.An internal visual inspection was performed and passed.The performance log was reviewed finding no errors related to the complaint.The probable cause of no vibration was determined to be a defective vibrator motor.No injury or medical intervention was reported.
Event or Problem Description
Verified a defective vibrator motor with high resistance measured ¿0.987 m¿ (known good resistance is 18¿ +/-20%).
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).B5: describe event or problem - correction.H2: correction.

• 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 ; +1(858)200-0200
• MDR Report Key: 50774028
• Report Number: 3004753838-2026-251366
• Device Sequence Number: 21200198
• Product Code: QBJ
• UDI-Device Identifier: 00386270001900
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: MT24078
• Device Catalogue Number: STK-OE-001
• Device Lot Number: TJ2018525
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2021
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 130 LB