MalfunctionQII
DEXCOM G6 PROFESSIONAL SYSTEM
Received Nov 19, 2024 · Event occurred Oct 29, 2024
Report 3004753838-2024-302204 · MDR key 20717814
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Catalog number
STP-PR-001
Lot number
5343088
Product problems
- Wireless Communication Problem
- Wireless Communication Problem
Patient
41 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Additional Manufacturer Narrative
(B)(4).