FDA Adverse Event
Malfunction
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 4840536
·
Received June 11, 2015
Report
- Report Number
- 3007981285-2015-33899
- Event Type
- Malfunction
- Date Received
- June 11, 2015
- Date of Event
- May 14, 2015
- Report Date
- May 14, 2015
- Manufacturer
- TANDEM DIABETES CARE INC.
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVAL. SHOULD ADDITIONAL INFO BE RECEIVED A SUPPLEMENTAL FORM WILL BE COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP SHUT OF UNEXPECTEDLY AT 30% BATTERY LIFE AND BECAME UNRESPONSIVE. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 383101 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | LZG | TANDEM DIABETES CARE INC. | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |