MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jul 8, 2026 · Event occurred Jun 15, 2026
Report 3004753838-2026-190844 · MDR key 25748792
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9500-174Catalog number
STP-XN-001
Lot number
1825204003
Product problems
- Overheating of Device
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SENSOR WAS OVERHEATING. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Additional Manufacturer Narrative
(B)(4).