MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 18, 2026 · Event occurred Jun 9, 2026
Report 3004753838-2026-177106 · MDR key 25549439
Device
Product problems
- Detachment of Device or Device Component
Patient
58 YR · Female
- 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 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).