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

Model Number	9500-174
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	08/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a broken or detached wire occurred.The sensor was inserted 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).B5: describe event or problem - additional information.D9 device available for evaluation - correction.D9: device returned to mfr - additional information.D9: date device returned - additional information.H2 type of follow up: additional information/ device evaluation/correction.H3a: device evaluated by mfg- additional information.H3b: evaluation included - additional information.H6: additional information.
Event or Problem Description
It was reported that a wire/needle/cannula damaged or missing occurred.The sensor was inserted on (b)(6) 2025.Product was provided for investigation.An external visual inspection was performed and passed/failed.Internal visual inspection was performed and passed.The allegation was undetermined via product.The probable cause 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: 22968614
• Report Number: 3004753838-2025-246960
• Device Sequence Number: 13049217
• Product Code: SAF
• UDI-Device Identifier: 00386270004338
• UDI-Public: (01)00386270004338(11)250201(17)260731(10)1725054003
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: 07/31/2026
• Device Model Number: 9500-174
• Device Catalogue Number: STP-XN-001
• Device Lot Number: 1725054003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/17/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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: 63 YR
• Patient Sex: Unknown