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

Model Number	9445-24
Medical Device Problem Code	Wireless Communication Problem (3283)
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).
Event or Problem Description
It was reported that signal loss occurred.The product was evaluated.An external visual inspection was performed and passed.Perform voltage test was performed and failed.Performance data was reviewed but does not reflect the full investigation window.The allegation and a probable cause could not be determined.No injury or medical intervention was reported.It was indicated the patient started their transmitter past the 'use by' date, which is misuse of the device.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that signal loss occurred it was indicated the patient started their transmitter past the 'use by' date, which is misuse of the device.Data was received but does not reflect full investigation window.The allegation and a probable cause could not be determined.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: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 23072588
• Report Number: 3004753838-2025-261015
• Device Sequence Number: 21271191
• Product Code: QBJ
• UDI-Device Identifier: 00386270001627
• UDI-Public: (01)00386270001627(11)231004(17)241002(10)5333816
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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: 10/02/2024
• Device Model Number: 9445-24
• Device Catalogue Number: STT-GS-007
• Device Lot Number: 5333816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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: TANDEM TSLIM X2 INSULIM PUMP
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 145 KG