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

Model Number	9500-174
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a broken sensor wire occurred.The sensor was inserted into the back of upper arm on (b)(6) 2025.Data was received but not investigated as data will not confirm the issue.The allegation and a probable cause could not be determined.No injury or medical intervention was reported.
Additional Manufacturer Narrative
(b)(4).

• 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: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 22999337
• Report Number: 3004753838-2025-250327
• Device Sequence Number: 13128764
• Product Code: SAF
• UDI-Device Identifier: 00386270004338
• UDI-Public: (01)00386270004338(11)250601(17)261130(10)1825164020
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/08/2025

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 Model Number: 9500-174
• Device Catalogue Number: STP-XN-001
• Device Lot Number: 1825164020
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2025
• 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
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Unknown