N
Patient 1
(B)(4).
MAUDE MDR 7558992
- MDR report key
- 7558992
- Report number
- 3004753838-2018-056219
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-05-03
- Date received
- 2018-05-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR KIPP DURBIN
- Address
- 6340 SEQUENCE DR. SAN DIEGO CA 92121 US
- Phone
- 858-858-8582
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | DEXCOM, INC. | N/A | SW10611 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-05-31 | 0 |
Event Narratives#
D
Patient 1
DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. A DATA INVESTIGATION WILL NOT BE PERFORMED AS SIGNAL LOSS UP TO ONE HOUR IS WITHIN SPECIFICATION. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.