MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 22, 2026 · Event occurred May 31, 2026
Report 3004753838-2026-178924 · MDR key 25588597
Device
Product problems
- Break
Patient
73 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A BROKEN SENSOR WIRE OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Additional Manufacturer Narrative
(B)(4).