MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 15, 2026 · Event occurred Jun 2, 2026
Report 3004753838-2026-174013 · MDR key 25512564
Device
Product problems
- Detachment of Device or Device Component
Patient
56 YR · Female
- 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. THE BIOSENSOR 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 SERIOUS OR PROLONGED PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED.