MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 11, 2026 · Event occurred May 15, 2026
Report 3004753838-2026-171977 · MDR key 25480385
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 THE NEEDLE WAS MISSING. 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.