FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 10603212
·
Received September 29, 2020
Report
- Report Number
- 3004753838-2020-110853
- Event Type
- Malfunction
- Date Received
- September 29, 2020
- Date of Event
- August 25, 2020
- Report Date
- October 20, 2020
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270000255
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
COM-(B)(4).
Description of Event or Problem · 0
INITIALLY THIS EVENT WAS REPORTED AS A REPORTABLE MALFUNCTION. UPON FURTHER REVIEW IT WAS DETERMINED THAT THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE COMPLAINT. MFR 3004753838-2020-110853 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT SINCE THIS HAS NOW BEEN DEEMED NON-REPORTABLE."
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A BROKEN SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED AT THE THIGH, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2020. NO PRODUCT WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1065689 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-45 | NI | 00386270000255 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |