MAUDE Adverse Event Report: Dexcom, Inc. Dexcom G7 Continuous Glucose Monitoring System

Model Number	9500-161
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that wearable not working occurred.Analysis indicated the lot number for this complaint record is associated with the third-party unauthorized product release and use of non-conforming product that was scrapped by dexcom.The third party acted as an unauthorized remanufacturer under 21 cfr 820.3 and engaged in prohibited actions under 21 u.S.C.§ 331 without dexcom¿s knowledge or approval.This is documented in capa-000611 and fas-sd-26-002.No injury or medical intervention was reported.No further investigation is required.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: Dexcom G7 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: 50544843
• Report Number: 3004753838-2026-240762
• Device Sequence Number: 10311847
• Product Code: QBJ
• UDI-Device Identifier: 00386270004109
• UDI-Public: (01)00386270004109(11)250701(17)261231(10)1725204004
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: 9500-161
• Device Catalogue Number: STP-AT-012
• Device Lot Number: 1725204004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2574-2026
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 210 LB