MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jul 8, 2026 · Event occurred Jun 12, 2026
Report 3004753838-2026-191514 · MDR key 25752915
Device
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
(B)(4)
Description of Event or Problem
IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. 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.