MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 9, 2026 · Event occurred May 16, 2026
Report 3004753838-2026-168242 · MDR key 25443265
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9500-174Catalog number
STP-XN-001
Lot number
1825163005
Product problems
- Detachment of Device or Device Component
Patient
49 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE NEEDLE WAS DETACHED. 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.