FDA Adverse Event
Malfunction
Summary report: N
T:FLEX INSULIN DELIVERY SYSTEM
MDR report key: 11348890
·
Received February 19, 2021
Report
- Report Number
- 3013756811-2021-20399
- Event Type
- Malfunction
- Date Received
- February 19, 2021
- Date of Event
- January 29, 2021
- Report Date
- February 19, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004569
- PMA / PMN Number
- K143189
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING BASAL DELIVERY WITH MULTIPLE CARTRIDGES. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 140-400 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248176 | T:FLEX INSULIN DELIVERY SYSTEM | INFUSION PUMP | LZG | TANDEM DIABETES CARE | 004628-005 | 00852162004569 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |