MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 30, 2026 · Event occurred Jun 10, 2026
Report 3004753838-2026-184539 · MDR key 25667085
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
53 YR · Female
- 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 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.