MAUDE Adverse Event Report: Dexcom, Inc. Stelo Glucose Biosensor System; Continuous Glucose Monitor

Catalog Number	STP-XN-002
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction

• Brand Name: Stelo Glucose Biosensor 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: 50140175
• Report Number: 3004753838-2026-216003
• Device Sequence Number: 9110517
• Product Code: SAF
• UDI-Device Identifier: 00386270004383
• UDI-Public: (01)00386270004383
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K234070
• 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): 08/05/2026

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: STP-XN-002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 50 YR
• Patient Sex: Female