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

Model Number	9535-45
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred frequently between 8/28/2026 and 8/31/2026.The sensor was inserted into an off-label insertion site, on (b)(6) 2026.Data was provided for investigation.The allegation was confirmed due to the finding of inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred rarely within the investigation window.The probable cause of the inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter could not be determined.The reported glucose values fall within the d zone of the parkes error grid.The data investigation found a difference in values that fall within the b zone of the parkes error grid.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 (Section G): Dexcom, Inc.; 232 s dobson rd; mesa AZ 85202
• Manufacturer Contact: jaime chavez ; 6340 sequence dr.; san diego, CA 92121 ; +1(858)200-0200
• MDR Report Key: 50842720
• Report Number: 3004753838-2026-255429
• Device Sequence Number: 16020024
• Product Code: QBJ
• UDI-Device Identifier: 00386270000866
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/21/2026

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: 9535-45
• Device Catalogue Number: STS-OE-003
• Device Lot Number: 7389745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2026
• 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: Omnipod 5
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 120 LB