MAUDE Adverse Event Report: DEXCOM, INC. STELO GLUCOSE BIOSENSOR SYSTEM; CONTINUOUS GLUCOSE MONITOR

Catalog Number	SW14116
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Unspecified Infection (1930); Foreign Body In Patient (2687)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a detached or missing sensor wire occurred.The biosensor was inserted on (b)(6) 2026.No data was provided for evaluation.The allegation and the probable cause could not be determined.No serious or prolonged patient harm or medical intervention was reported.

• 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 ; 8582000200
• MDR Report Key: 25610686
• Report Number: 3004753838-2026-180516
• Device Sequence Number: 9942157
• Product Code: SAF
• UDI-Device Identifier: 00386270004635
• UDI-Public: (01)00386270004635
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: SW14116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Unknown