FDA Adverse Event
Malfunction
Summary report: N
ILET BETA BIONIC PUMP
MDR report key: 20302226
·
Received September 24, 2024
Report
- Report Number
- MW5160027
- Event Type
- Malfunction
- Date Received
- September 24, 2024
- Date of Event
- August 27, 2024
- Report Date
- September 18, 2024
- Manufacturer
- BETA BIONICS, INC.
- Product Code
- QFG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
INSULIN CARTRIDGE LEAKED AND PT HAD BG OF 600. 3RD TIME THE COMPANY HAS REPLACED THE PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1199264 | ILET BETA BIONIC PUMP | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | BETA BIONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Other |