FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8191407
·
Received December 21, 2018
Report
- Report Number
- 3004753838-2018-160895
- Event Type
- Malfunction
- Date Received
- December 21, 2018
- Date of Event
- November 12, 2018
- Report Date
- November 28, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). PLEASE DISREGARD ALL INFORMATION THAT WAS REPORTED IN THE INITIAL MDR FOR REPORT NUMBER 3004753838-2018-160895 AS THIS IS A DUPLICATE REPORT. THIS CUSTOMER COMPLAINT HAS BEEN PREVIOUSLY REPORTED IN REPORT NUMBER 3004753838-2018-151894.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. LOSS OF CONNECTION COULD NOT BE DETERMINED. THE ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1029829 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | 9438-05 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |