Stelo Glucose Biosensor System
Received Jul 30, 2026 · Event occurred Jul 18, 2026
Report 3004753838-2026-210929 · MDR key 50090138
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
- Purulent Discharge
- Erythema
- Pain
- Rash
- Skin Inflammation/ Irritation
- Swelling/ Edema
Narrative
Description of Event or Problem
It was reported via SteloBot that a skin reaction occurred. The biosensor was inserted into the back of upper arm on (b)(6)2026. Prior to sensor insertion the area was prepped with alcohol. On (b)(6)2026, the customer had a Brief Sensor Issue and a skin reaction. The customer had removed the sensor and noticed that it was infected, with puss coming out, along with redness and pain on the insertion site. The following day on (b)(6)2026, the customer went to the doctor's to have it checked out. The customer was given a prescription oral antibiotic Bactrim. No dosage was provided and customer was advised to take it as needed. It was also noted that no ointment was prescribed. At the time of the report, the customer's condition was unknown but stated that they have a follow up appointment with the doctor on (b)(6)2019. 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).