MalfunctionSAF
Stelo Glucose Biosensor System
Received Jul 27, 2026 · Event occurred Jul 1, 2026
Report 3004753838-2026-203762 · MDR key 50006454
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9500-174Catalog number
STP-XN-001
Lot number
1825350004
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that a broken or detached 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).This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.