FDA Adverse Event
Malfunction
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 7961276
·
Received October 12, 2018
Report
- Report Number
- 3013756811-2018-31993
- Event Type
- Malfunction
- Date Received
- October 12, 2018
- Date of Event
- August 26, 2018
- Report Date
- October 12, 2018
- 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
SERIAL NUMBERS: (B)(4). LOT NUMBERS: M021510, M022046, POSSIBLE USE ERRORS: OVERFILLING THE CARTRIDGE OR REUSING THE CARTRIDGE. THE T:SLIM USER GUIDE STATES: "THE SINGLE-USE DISPOSABLE CARTRIDGE CAN HOLD UP TO 300 UNITS (3.0 ML) OF INSULIN."
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 |
|---|---|---|---|---|---|---|---|
| 800868 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |