FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8656761
·
Received May 30, 2019
Report
- Report Number
- 3004753838-2019-45895
- Event Type
- Malfunction
- Date Received
- May 30, 2019
- Date of Event
- April 30, 2019
- Report Date
- May 30, 2019
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). MODEL #/CATALOG #/SERIAL #/LOT #/EXPIRATION DATE - CORRECTION "9500-46, STS-GS-003, NA, 5251279, 23-JAN-2020"DEVICE MANUFACTURE DATE - CORRECTION "22-FEB-2019". LABELED FOR SINGLE USE - CORRECTION "YES."
Description of Event or Problem · 1
IT WAS REPORTED THAT AN EARLY SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2019. IT WAS DETERMINED THAT THE ISSUE WAS RELATED TO THE MOBILE APPLICATION. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Description of Event or Problem · 1
DATA WAS RECEIVED BUT DOES NOT REFLECT FULL INVESTIGATION WINDOW. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 449767 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9445-02 | 5247680 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR |