STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 15, 2026 · Event occurred May 29, 2026
Report 3004753838-2026-173623 · MDR key 25507377
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9500-174Catalog number
STP-XN-001
Lot number
1825237002
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). 3004753838-2026-173623 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
Description of Event or Problem
AFTER SUBMISSION OF THE INITIAL MDR PRODUCT WAS RECEIVED ON 6/25/2026 IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE NEEDLE WAS BENT. THE SENSOR WAS INSERTED INTO THE ABDOMEN, WHICH IS OFF-LABEL USAGE OF THE DEVICE. 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.