MalfunctionPQM
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Received Jan 27, 2018 · Event occurred Dec 29, 2017
Report 3004753838-2018-009933 · MDR key 7223897
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9438-06Catalog number
STT-GF-001
Lot number
6002678
Product problems
- Wireless Communication Problem
- Wireless Communication Problem
Patient
61 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 12/30/2017 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 PROVIDED FOR INVESTIGATION. CONFIRMATION OF THE COMPLAINT WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA.