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

Model Number	9500-174
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a skin reaction was occurred.On (b)(6) 2025, it was reported that a skin reaction at the puncture site occurred.After sensor insertion the customer developed an infection at the insertion site.They stated, ¿got an infection at the site of insertion.Had to go to urgent care and take antibiotics.¿ the name of the antibiotic, date and site of insertion was not specified.No other customer details were available.No data or product was provided for investigation.The allegation was undetermined.The probable cause could not 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).
Event or Problem Description
Subsequent to the initial mdr, a correction is required.It was reported that a skin reaction occurred.The sensor was inserted into the arm on (b)(6) 2025.Date of event is an approximation.On 07/28/2025, it was reported that a skin reaction at the puncture site occurred.After sensor insertion the customer developed an infection at the insertion site.They stated, ¿got an infection at the site of insertion.Had to go to urgent care and take antibiotics.¿ the name of the antibiotic, date and site of insertion was not specified.No other customer details were available.No data or product was provided for investigation.The allegation was undetermined.The probable cause could not be determined.No additional patient or event information is available.
Additional Manufacturer Narrative
B3 date of event - correction.B5 describe event or problem - correction.

• 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: 22926993
• Report Number: 3004753838-2025-241758
• Device Sequence Number: 10389756
• Product Code: SAF
• UDI-Device Identifier: 00386270004338
• UDI-Public: 00386270004338
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/11/2025

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: 1725127002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 08/31/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male