FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP
MDR report key: 7739342
·
Received August 1, 2018
Report
- Report Number
- 3013756811-2018-25947
- Event Type
- Malfunction
- Date Received
- August 1, 2018
- Date of Event
- July 8, 2018
- Report Date
- August 1, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004781509068
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP BATTERY WAS INTERMITTENTLY OBSERVED TO BE DEPLETING QUICKLY, WHICH LED TO A PUMP SHUTDOWN. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED FROM 171-378 MG/DL. THE CUSTOMER INDICATED THAT EITHER THE PUMP OR MANUAL INJECTIONS WOULD BE USED FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 581220 | T:SLIM X2 INSULIN PUMP | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 1000096 | 00852162004781509068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR |