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 Codes	Hypoglycemia (1912); Insufficient Information (4580)
Date of Event	09/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a wearable failure occurred.The biosensor was inserted into the back of upper arm on (b)(6) 2026.On (b)(6) 2026 the wearable failed.The customer replied ¿yes¿ to the medical intervention question, and indicated they had unspecified hypoglycemia symptoms.The consumer described the medical intervention as ¿hospital.¿ at the time of the report on (b)(6) 2026 they were recovering.Although requested, no other details were provided, and they did not respond to additional requests for information.Data has been requested but is pending evaluation.A follow up report will be submitted upon completion.No additional event or patient information is available.
Additional Manufacturer Narrative
(b)(4).H6 medical device problem code - 3191 - patient was unable to identify device issue therefore a more specific code could not be selected.Diabetes mellitus is a known cause of hypoglycemia.¿.

• 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 (Section G): Dexcom, Inc.; 232 s dobson rd; mesa AZ 85202
• Manufacturer Contact: jaime chavez ; 6340 sequence dr.; san diego, CA 92121 ; +1(858)200-0200
• MDR Report Key: 50947727
• Report Number: 3004753838-2026-263743
• Device Sequence Number: 9624427
• Product Code: SAF
• UDI-Device Identifier: 00386270004345
• UDI-Public: (01)00386270004345(11)260701(17)271231(10)1726197006
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/30/2026

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 Model Number: 9500-174
• Device Catalogue Number: STP-XN-001
• Device Lot Number: 1726197006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/20/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 180 LB