MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jul 2, 2026 · Event occurred Jun 7, 2026
Report 3004753838-2026-187261 · MDR key 25694943
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
60 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A BROKEN OR DETACHED WIRE OCCURRED. THE SENSOR WAS INSERTED 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.