FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 PROFESSIONAL SYSTEM
MDR report key: 11609222
·
Received April 2, 2021
Report
- Report Number
- 3004753838-2021-61753
- Event Type
- Malfunction
- Date Received
- April 2, 2021
- Date of Event
- March 18, 2021
- Report Date
- April 2, 2021
- Manufacturer
- DEXCOM, INC.
- Product Code
- QII
- PMA / PMN Number
- K191833
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A LOSS OF CONNECTION WAS FOUND WITHIN THE INVESTIGATION WINDOW. HOWEVER, THE DEVICE OPERATED WITHIN SPECIFICATION. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 505593 | DEXCOM G6 PROFESSIONAL SYSTEM | CONTINUOUS GLUCOSE MONITOR | QII | DEXCOM, INC. | 9445-20 | 5282576 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |