STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 8, 2026 · Event occurred May 13, 2026
Report 3004753838-2026-167513 · MDR key 25430901
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9500-174Catalog number
STP-XN-001
Lot number
1825125004
Product problems
- Detachment of Device or Device Component
- Appropriate Device Problem Term/Code Not Available
Patient
49 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT"WIRE/NEEDLE/CANNULA DAMAGE OR MISSING" OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND THE PROBABLE CAUSE CANNOT BE DETERMINED.
Additional Manufacturer Narrative
(B)(4).
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).