MalfunctionQDK
DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM
Received Jun 2, 2025 · Event occurred Apr 29, 2025
Report 3004753838-2025-135963 · MDR key 22124353
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Catalog number
STT-OE-002
Lot number
18038708
Product problems
- Wireless Communication Problem
- Wireless Communication Problem
Patient
42 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS CONFIRMED DUE TO THE FINDING OF SIGNAL LOSS OVER AN HOUR WITHIN THE INVESTIGATION WINDOW. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.