MAUDE Adverse Event Report: Dexcom, Inc. Stelo Glucose Biosensor System; Continuous Glucose Monitor

Catalog Number	STP-XN-002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735); Erythema (1840); Fever (1858); Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via email that a skin reaction occurred.Additional information indicated that a skin reaction occurred at the sensor insertion site following sensor insertion into the arm on (b)(6)2026.The customer reported, "i had an issue with the sensor early wednesday morning when i was awakened in a lot of pain.The back of my arm kept hurting bad enough that i had to remove the sensor.There was a knot present, pain, redness, and a fever at the site.Since the redness, swelling, pain, and fever have gotten worse to the point where i am now at an er." the reported skin reaction included pain, redness, swelling, a knot at the insertion site, and fever.Due to worsening symptoms, the customer sought evaluation and treatment in the emergency department (er).No treatment information was provided, and no additional details regarding the event or outcome were available at the time of the report.No product or data was provided for investigation.Problem could not be confirmed and probable cause cannot be determined.No additional patient or event information is available.
Additional Manufacturer Narrative
(b)(4).Labeling indicates: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (e.G.Redness, swelling, bruising, itching, scarring or skin discoloration).

• 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 ; +1(858)200-0200
• MDR Report Key: 50262172
• Report Number: 3004753838-2026-225832
• Device Sequence Number: 16124436
• Product Code: SAF
• UDI-Device Identifier: 00386270004383
• UDI-Public: (01)00386270004383
• 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: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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: STP-XN-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 57 YR
• Patient Sex: Male