MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jul 8, 2026 · Event occurred Jun 10, 2026
Report 3004753838-2026-191501 · MDR key 25752882
Device
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4)
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A NEEDLE ISSUE. THE SENSOR WAS INSERTED ON (B)(6) 2026. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.