FDA Adverse Event
Malfunction
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 8251196
·
Received January 15, 2019
Report
- Report Number
- 3013756811-2019-02246
- Event Type
- Malfunction
- Date Received
- January 15, 2019
- Date of Event
- October 1, 2018
- Report Date
- January 15, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PUMP SERIAL NUMBERS: (B)(4). CARTRIDGE LOT NUMBERS: M102672, M017775, M021826.
Description of Event or Problem · 1
QUARTERLY SUMMARY REPORT FOR ALLEGED CARTRIDGE LEAKING: IT WAS REPORTED THAT THE CARTRIDGE WAS LEAKING INSULIN OR INSULIN WAS OBSERVED ON OR AROUND THE PUMP. ISSUE WAS RESOLVED BY LOADING A NEW CARTRIDGE OR CONTINUING TO USE THE SAME CARTRIDGE. THERE WAS NO ADVERSE EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43141 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |