FDA Adverse Event
Malfunction
Summary report: N
V-GO DISPOSABLE INSULIN DELIVERY DEVICE
MDR report key: 20063636
·
Received August 26, 2024
Report
- Report Number
- 1226572-2024-00048
- Event Type
- Malfunction
- Date Received
- August 26, 2024
- Date of Event
- August 3, 2024
- Report Date
- August 5, 2024
- Manufacturer
- MANNKIND CORPORATION - V-GO
- Product Code
- LZG
- UDI-DI
- 00385609400025
- PMA / PMN Number
- K103825
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
THE PATIENT REPORTED THAT THREE V-GO DEVICES HAVE FALLEN OFF. IT WAS REPORTED THAT A DEVICE SAMPLE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, HAS NOT BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1480800 | V-GO DISPOSABLE INSULIN DELIVERY DEVICE | V-GO | LZG | MANNKIND CORPORATION - V-GO | V-GO 30 | FG323123 | 00385609400025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Disability |