MalfunctionPQM
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Received Feb 9, 2018 · Event occurred Nov 13, 2017
Report 3004753838-2018-014819 · MDR key 7261599
Device
Product problems
- Wireless Communication Problem
- Wireless Communication Problem
Patient
16 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
DEXCOM WAS MADE AWARE ON (B)(4) 2018 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 PROBABLE CAUSE COULD NOT BE DETERMINED.