N
Patient 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
MAUDE MDR 9907949
- MDR report key
- 9907949
- Report number
- 3013756811-2020-31559
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-08
- Date received
- 2020-03-31
- 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
- MICK TRIER
- Address
- SAN DIEGO CA 92121 US
- Phone
- 858-858-8584
- 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 G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | DEXCOM, INC. | QBJ | STT-OR-001 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. IN ADDITION, IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INVALID TRANSMITTER ID ALERT. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE STARTED. TRANSMITTER WAS REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.