FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6032250
·
Received October 15, 2016
Report
- Report Number
- 3004753838-2016-84325
- Event Type
- Malfunction
- Date Received
- October 15, 2016
- Date of Event
- September 24, 2016
- Report Date
- September 24, 2016
- Manufacturer
- DEXCOM INC.
- Product Code
- MDS
- UDI-DI
- 00386270000101
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THE RECEIVER DISPLAYED A HARDWARE ERROR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 683449 | DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM INC. | MT22430-PNK | 5195745 | 00386270000101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR |