FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6580313
·
Received May 20, 2017
Report
- Report Number
- 3004753838-2017-42305
- Event Type
- Malfunction
- Date Received
- May 20, 2017
- Date of Event
- April 30, 2017
- Report Date
- April 30, 2017
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 10386270000061
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR HWR. 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 |
|---|---|---|---|---|---|---|---|
| 361685 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | MT20649 | 5191118 | 10386270000061 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |