FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 6096551
·
Received November 11, 2016
Report
- Report Number
- 3007981285-2016-19485
- Event Type
- Malfunction
- Date Received
- November 11, 2016
- Date of Event
- October 20, 2016
- Report Date
- October 20, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT OUT OF RANGE ISSUES OCCURRED BETWEEN THE TRANSMITTER AND PUMP, WITH NO CONTINUOUS GLUCOSE MONITOR (CGM) SENSOR READINGS. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. MANUAL INJECTIONS WILL BE USED FOR DIABETES MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 746719 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |