MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 9, 2026 · Event occurred May 17, 2026
Report 3004753838-2026-168243 · MDR key 25443474
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9500-174Catalog number
STP-XN-001
Lot number
1825122014
Product problems
- Break
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 BROKEN. THE SENSOR WAS INSERTED INTO THE BACK OF 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.