FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6178080
·
Received December 15, 2016
Report
- Report Number
- 3004753838-2016-53544
- Event Type
- Malfunction
- Date Received
- December 15, 2016
- Date of Event
- September 7, 2016
- Report Date
- November 24, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- 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).
Description of Event or Problem · 1
THE PRODUCT WAS NOT AVAILABLE FOR TESTING. THE ALLEGATION WAS UNDETERMINED. THE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON 11/08/2016 THAT ON (B)(6) 2016, PATIENT EXPERIENCED A FAILED TRANSMITTER ERROR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 826001 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | 9438-06 | 5208788 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |