STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 24, 2026 · Event occurred Mar 12, 2026
Report 3004753838-2026-180872 · MDR key 25613174
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9500-174Catalog number
STP-XN-001
Lot number
1825202011
Product problems
- Break
Patient
70 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN APPLICATOR DEPLOYMENT ISSUE OCCURRED. THE SENSOR WAS INSERTED INTO THE BACK OF UPPER ARM , WHICH IS OFF-LABEL USAGE OF THE DEVICE. THE APPLICATOR WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO BROKEN NEEDLE. THE WEARABLE WAS ALSO PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND HAD MAJOR DAMAGE DUE TO GOOSENECK. THE ALLEGATION OF APPLICATOR DEPLOYMENT WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. ADDITIONALLY, A GOOSENECKING WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED
Additional Manufacturer Narrative
(B)(4).