FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8081255
·
Received November 16, 2018
Report
- Report Number
- 3004753838-2018-140524
- Event Type
- Malfunction
- Date Received
- November 16, 2018
- Date of Event
- October 18, 2018
- Report Date
- October 18, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- P170031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PLEASE DISREGARD ALL INFORMATION THAT WAS REPORTED IN THE INITIAL MDR FOR REPORT NUMBER 3004753838-2018-140524 AS THIS IS A DUPLICATE REPORT. THIS CUSTOMER COMPLAINT HAS BEEN PREVIOUSLY REPORTED IN REPORT NUMBER 3004753838-2018-140531.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2018. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED. REVIEW OF THE DATA LOG CONFIRMED THE REPORT OF AN INACCURACY. A ROOT CAUSE COULD NOT BE DETERMINED VIA DATA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 919067 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-46 | 5242340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR |