FDA Adverse Event
Malfunction
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 4962016
·
Received July 31, 2015
Report
- Report Number
- 3007981285-2015-50561
- Event Type
- Malfunction
- Date Received
- July 31, 2015
- Date of Event
- July 9, 2015
- Report Date
- July 9, 2015
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVAL. SHOULD NEW RELEVANT INFO BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A LOW BATTERY POWER ALERT BECAME FROZEN ON THE PUMP SCREEN AND THE CUSTOMER WAS UNABLE TO CLEAR THE ALERT. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE ALERT WAS ABLE TO BE CLEARED. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 499119 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |