FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 4920312
·
Received July 16, 2015
Report
- Report Number
- 3004753838-2015-05901
- Event Type
- Malfunction
- Date Received
- July 16, 2015
- Date of Event
- June 9, 2015
- Report Date
- June 23, 2015
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- 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). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE DATA LOG WAS PROVIDED BY THE PATIENT. THE DATA WAS REVIEWED ON (B)(6) 2015 AND CONFIRMED THE REPORTED EVENT OF INTERMITTENT OUT OF RANGE. A DEFINITIVE ROOT CAUSE, HOWEVER, COULD NOT BE DETERMINED.
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, PATIENT EXPERIENCED AN INTERMITTENT OUT OF RANGE SIGNAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462987 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9438-05 | 5194077 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |