FDA Adverse Event
Malfunction
Summary report: N
T:FLEX INSULIN DELIVERY SYSTEM
MDR report key: 8518766
·
Received April 16, 2019
Report
- Report Number
- 3013756811-2019-04998
- Event Type
- Malfunction
- Date Received
- April 16, 2019
- Date of Event
- January 1, 2019
- Report Date
- April 16, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004385
- PMA / PMN Number
- K143189
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
POSSIBLE USE ERRORS: OVERFILLING THE CARTRIDGE BAG. PER TANDEM¿S T:FLEX USER GUIDE: "THE SINGLE-USE DISPOSABLE CARTRIDGE CAN HOLD UP TO 480 UNITS (4.8ML) OF INSULIN.¿ (B)(4), CARTRIDGE LOT NUMBERS: M172912, M107212.
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 |
|---|---|---|---|---|---|---|---|
| 314254 | T:FLEX INSULIN DELIVERY SYSTEM | INFUSION PUMP | LZG | TANDEM DIABETES CARE | 004628-005 | 00852162004385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INFUSION SET, INSULIN |