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

Model Number	9500-174
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	07/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that an applicator deployment occurred.The sensor was inserted into the back of upper arm.Product was provided for investigation.An external visual inspection was performed and passed due to no damage.The internal visual inspection was performed and failed due detached needle.An applicator deployment was not found within the investigation window.The allegation was not confirmed.However, a broken or detached needle or cannula was found in connection to the reported event.The probable cause of the broken or detached needle or cannula could not be determined.No injury 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: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 23096324
• Report Number: 3004753838-2025-264604
• Device Sequence Number: 9504395
• Product Code: SAF
• UDI-Device Identifier: 00386270004338
• UDI-Public: (01)00386270004338(11)250301(17)260831(10)1725084001
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/19/2025

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 Expiration Date: 08/31/2026
• Device Model Number: 9500-174
• Device Catalogue Number: STP-XN-001
• Device Lot Number: 1725084001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• 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: 54 YR
• Patient Sex: Unknown