MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 9, 2026 · Event occurred May 20, 2026
Report 3004753838-2026-168881 · MDR key 25448434
Device
Product problems
- Break
Patient
54 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE NEEDLE WAS BROKEN. THE SENSOR WAS INSERTED INTO THE BACK OF THE 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 INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Additional Manufacturer Narrative
(B)(4).