N
Patient 1
THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.
MAUDE MDR 9908404
- MDR report key
- 9908404
- Report number
- 3013756811-2020-30319
- 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 | T:SLIM X2 INSULIN PUMP | INSULIN PUMP | TANDEM DIABETES CARE | LZG | 1000096 | 1000103 | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE PUMP COULD NOT BE INTERMITTENTLY CHARGED PROPERLY WITHOUT THE CUSTOMER MANEUVERING THE CABLE INTO THE CHARGING PORT DUE TO DAMAGE TO THE CHARGING PORT. SUBSEQUENTLY, IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. CUSTOMER'S BLOOD GLUCOSE REACHED 291 MG/DL. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.