DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Received Aug 1, 2018 · Event occurred Jun 26, 2018
Report 3004753838-2018-078471 · MDR key 7741635
Device
Generic name
Continuous Glucose Monitor
Manufacturer
Dexcom, Inc.Model number
9438-06Catalog number
STT-GF-001
Lot number
6006057
Product problems
- Connection Problem
- Connection Problem
Patient
33 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) 2018, A PAIRING FAILURE BETWEEN THE TRANSMITTER AND SMART DEVICE AND/OR RECEIVER OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. DATA REVIEW CONFIRMED THE REPORTED EVENT OF PAIRING FAILURE. THE ROOT CAUSE WAS DETERMINED TO BE A FAILED TRANSMITTER ERROR. REPORTED ISSUE OF PAIRING FAILURE IS REPORTABLE BASED ON THE FINDING OF TRANSMITTER FAILURE ERROR.
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. AN EXTERIOR PHYSICAL VISUAL INSPECTION WAS PERFORMED AND THE DEVICE PASSED. THE TRANSMITTER VOLTAGE WAS TESTED AND FAILED AT 0VDC. THE CLOUD/SHARE DATA WAS AVAILABLE. TRANSMITTER FATAL ERROR WAS FOUND IN SHARE LOG BUT NOT RELATED TO COMPLAINT.