MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 11, 2026 · Event occurred May 27, 2026
Report 3004753838-2026-171616 · MDR key 25477536
Device
Product problems
- Detachment of Device or Device Component
Patient
64 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. 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.