MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 16, 2026 · Event occurred May 25, 2026
Report 3004753838-2026-174500 · MDR key 25520035
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9500-174Catalog number
STP-XN-001
Lot number
1825320011
Product problems
- Detachment of Device or Device Component
Patient
61 YR · Unknown
- Foreign Body In Patient
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).