MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 12, 2026 · Event occurred May 27, 2026
Report 3004753838-2026-172719 · MDR key 25490715
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9500-174Catalog number
STP-XN-001
Lot number
1825350004
Product problems
- Overheating of Device
Patient
48 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SENSOR WAS PRODUCING OVERHEATING OR SHOCKING. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND THE PROBABLE CAUSE CANNOT BE DETERMINED.
Additional Manufacturer Narrative
(B)(4).