DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Received Aug 1, 2018 · Event occurred May 11, 2018
Report 3004753838-2018-078472 · MDR key 7741637
Device
Product problems
- Connection Problem
- Connection Problem
Patient
4 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, RECEIVER, AND SMART DEVICE OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. DATA WAS PROVIDED FOR EVALUATION. DATA REVIEW DID NOT CONFIRM THE REPORTED EVENT OF PAIRING FAILURE. A ROOT CAUSE COULD NOT BE DETERMINED VIA DATA. THE 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
PRODUCT WAS RETURNED. AN EXTERIOR PHYSICAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A VOLTAGE MEASUREMENT WAS TAKEN AND FAILED AT 0 VDC. A SHARE LOG REVIEW WAS PERFORMED AND A FAILURE TO PAIR WAS FOUND. A FATAL ERROR WAS OBSERVED FOR A DIFFERENT TX ID (B)(4) AND IS NOT RELATED TO THIS INVESTIGATION. THE ALLEGED TRANSMITTER HAS ALREADY BEEN SCRAPPED.