FDA Adverse Event
Malfunction
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 4181247
·
Received October 14, 2014
Report
- Report Number
- 3007981285-2014-09343
- Event Type
- Malfunction
- Date Received
- October 14, 2014
- Date of Event
- September 19, 2014
- Report Date
- September 19, 2014
- Manufacturer
- TANDEM DIABETES CARE INC.
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED FOR EVAL. HOWEVER, THE EVAL IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF EVAL.
Description of Event or Problem · 1
RECEIVED INFO THAT PUMP HAS STOPPED ALL INSULIN DELIVERY. REPORTEDLY, THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 648734 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE INC. | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |