FDA Adverse Event
Malfunction
Summary report: N
T:FLEX INSULIN DELIVERY SYSTEM
MDR report key: 7742835
·
Received August 2, 2018
Report
- Report Number
- 3013756811-2018-27673
- Event Type
- Malfunction
- Date Received
- August 2, 2018
- Date of Event
- July 29, 2018
- Report Date
- August 2, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004385470515
- PMA / PMN Number
- K143189
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE, INTERMITTENT INACCURATE FILL ESTIMATES WERE RECEIVED AFTER LOADING THE CARTRIDGE ONTO THE PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 112-138 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 585068 | T:FLEX INSULIN DELIVERY SYSTEM | INFUSION PUMP | LZG | TANDEM DIABETES CARE | 004628-005 | M020663 | 00852162004385470515 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |