MalfunctionSAF
STELO GLUCOSE BIOSENSOR SYSTEM
Received Jun 23, 2026 · Event occurred May 27, 2026
Report 3004753838-2026-179149 · MDR key 25595049
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9500-174Catalog number
STP-XN-001
Lot number
1825191012
Product problems
- Unintended Electrical Shock
Patient
73 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING A MILD SHOCK IN THE CHEST WHILE USING 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.
Additional Manufacturer Narrative
(B)(4).