DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2016-41234
- Event Type
- Malfunction
- Date Received
- February 24, 2016
- Date of Event
- January 31, 2016
- Report Date
- January 31, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000224
- 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 ON (B)(6) 2016, TO REPORT THAT THE TRANSMITTER WAS NOT FOUND ON THE G5 MOBILE APP ON (B)(6) 2016. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED. PAIRING TEST WAS PERFORMED AND THE TEST DID NOT PASS. ADDITIONALLY THE RECEIVER (PART NUMBER STK-PR-PNK/SERIAL NUMBER (B)(4)/LOT NUMBER 5201274) BEING USED WITH THE TRANSMITTER WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. A REVIEW OF THE DOWNLOADED RECEIVER LOG CONFIRMED THE CUSTOMER COMPLAINT. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER. DATA WAS ALSO RECEIVED FROM THE PATIENT. A REVIEW OF THE DOWNLOADED DATA LOG DID NOT FIND ANY ERROR RELATED TO THE CUSTOMER COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115929 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9438-06 | 5208160 | 00386270000224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |