MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jul 6, 2026 · Event occurred May 22, 2026
Report 3004753838-2026-187919 · MDR key 25717660
Device
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE BACK OF UPPER ARM ON (B)(6) 2026. 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).