FDA Adverse Event
Malfunction
Summary report: N
T:FLEX INSULIN DELIVERY SYSTEM
MDR report key: 8812865
·
Received July 22, 2019
Report
- Report Number
- 3013756811-2019-20658
- Event Type
- Malfunction
- Date Received
- July 22, 2019
- Date of Event
- April 1, 2019
- Report Date
- July 22, 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
PUMP SERIAL NUMBERS: (B)(4). CARTRIDGE LOT NUMBER: M111343. DEVICE NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
QUARTERLY SUMMARY REPORT FOR ALLEGED ISSUES DURING THE LOAD FILL TUBING SEQUENCE: IT WAS REPORTED THAT INSULIN WAS NOT EXITING THE TUBING OR INSULIN DROPS WERE EXITING SLOWER THAN NORMAL. THE ISSUE WAS RESOLVED BY USING NEW SUPPLIES (CARTRIDGE AND/OR INFUSION SET). THERE WAS NO ADVERSE IMPACT TO THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 606250 | T:FLEX INSULIN DELIVERY SYSTEM | INFUSION PUMP | LZG | TANDEM DIABETES CARE | 004628-005 | 00852162004385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INFUSION SET, INSULIN |