MalfunctionPQM
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Received Jan 16, 2018 · Event occurred Dec 9, 2017
Report 3004753838-2018-005655 · MDR key 7195674
Device
Product problems
- Wireless Communication Problem
- Wireless Communication Problem
Patient
21 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED: (B)(4).
Description of Event or Problem
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017, A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND SMART DEVICE OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS RETURNED AND EVALUATED. THE REPORTED EVENT OF A LOSS OF CONNECTION WAS CONFIRMED VIA DATA. A ROOT CAUSE COULD NOT BE DETERMINED.