MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jul 13, 2026 · Event occurred Jun 16, 2026
Report 3004753838-2026-195481 · MDR key 25803960
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 ON (b)(6) 2026, NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Additional Manufacturer Narrative
(b)(4)