MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jul 14, 2026 · Event occurred Jun 22, 2026
Report 3004753838-2026-195996 · MDR key 25812817
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9500-174Catalog number
STP-XN-001
Lot number
1825193001
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. 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.
Additional Manufacturer Narrative
(B)(4).