Stelo Glucose Biosensor System
Received Jul 31, 2026 · Event occurred Jul 19, 2026
Report 3004753838-2026-212593 · MDR key 50104627
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9500-174Catalog number
STP-XN-001
Lot number
1825331016
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Skin Infection
Narrative
Description of Event or Problem
It was reported that a skin reaction was occurred. The biosensor was inserted into the skin. On 07/19/2026, via SteloBot chat, it was reported that the customer experienced a skin reaction. The customer indicated, ¿I got a severe infection from my stelo and had to remove it. I'm currently on antibiotics¿. Attempts to contact the customer for more details were not successful. No other customer or event details were available. Data was received but not investigated as data will not confirm the issue. The allegation and a probable cause could not be determined. No additional customer 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).