FDA Adverse Event
Injury
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 4178034
·
Received October 14, 2014
Report
- Report Number
- 3007981285-2014-09426
- Event Type
- Injury
- Date Received
- October 14, 2014
- Date of Event
- September 17, 2014
- Report Date
- September 17, 2014
- Manufacturer
- TANDEM DIABETES CARE, INC.
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION. IN ADDITION, T:SLIM USER GUIDE INDICATES PUP IS TO BE USED WITH INDIVIDUALS 12 YEARS AND GREATER; PATIENT IS (B)(6).
Description of Event or Problem · 1
THE CUSTOMER'S PUMP SHUT DOWN UNEXPECTEDLY AROUND 80% BATTERY LIFE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED BUT HAS LANTUS AND HUMALOG SYRINGES FOR BACKUP. THE CUSTOMER IS REPORTEDLY (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650585 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE, INC. | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Other |