MalfunctionQII
DEXCOM G6 PROFESSIONAL SYSTEM
Received Aug 21, 2024 · Event occurred Jul 30, 2024
Report 3004753838-2024-209394 · MDR key 20021473
Device
Product problems
- No Device Output
- No Device Output
Patient
84 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(6). E1 INITIAL REPORTER STATE - (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT A TRANSMITTER BATTERY ISSUE OCCURRED. DATA WAS RECEIVED BUT DOES NOT REFLECT FULL INVESTIGATION WINDOW. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.