DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2015-61622
- Event Type
- Malfunction
- Date Received
- September 22, 2015
- Date of Event
- September 3, 2015
- Report Date
- September 3, 2015
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000125
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
PATIENT'S MOTHER 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.
SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT TRANSMITTER WAS NOT RETURNED TO DEXCOM. THE RECEIVER (PART NUMBER STR-PR-BLU/SERIAL NUMBER (B)(4)/LOT NUMBER 5202083), BEING USED WITH THE COMPLAINT TRANSMITTER, WAS RETURNED ON 10/21/2015. THE RETURNED RECEIVER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT FIND ANY ERRORS RELATED TO THE CUSTOMER COMPLAINT. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. THE REPORTED EVENT OF AN INTERMITTENT OUT OF RANGE SIGNAL WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 625364 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9438-05 | 5201329 | 00386270000125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |