FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5591148
·
Received April 20, 2016
Report
- Report Number
- 3004753838-2016-09531
- Event Type
- Malfunction
- Date Received
- April 20, 2016
- Date of Event
- November 24, 2013
- Report Date
- November 25, 2013
- Manufacturer
- DEXCOM INC.
- Product Code
- MDS
- UDI-DI
- 00386270000064
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM ON 11/25/2013 TO REPORT THAT THE RECEIVER DISPLAYED A FIRMWARE ERROR ON (B)(6) 2013. THEY DID NOT REPORT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245333 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM INC. | MT20649 | 5091232 | 00386270000064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |