FDA Adverse Event
Malfunction
Summary report: N
V-GO DISPOSABLE INSULIN DELIVERY DEVICE
MDR report key: 20180268
·
Received September 10, 2024
Report
- Report Number
- 1226572-2024-00053
- Event Type
- Malfunction
- Date Received
- September 10, 2024
- Date of Event
- August 1, 2024
- Report Date
- August 19, 2024
- Manufacturer
- MANNKIND CORPORATION - V-GO
- Product Code
- LZG
- UDI-DI
- 00385609400018
- PMA / PMN Number
- K103825
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
THE PATIENT REPORTED THAT THE V-GO 40 DEVICES WERE HAVING ISSUES. IT WAS REPORTED THAT THE BUTTON WOULD POP OFF (RELEASE) AND THEY WERE NOT ABLE TO GET INSULIN. THE PATIENT REPORTED THAT THIS HAPPENED FOUR TIMES, HOWEVER NO SPECIFIC EVENT DATES WERE REPORTED. IT WAS REPORTED THAT ONE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER. HOWEVER, TO DATE, NO DEVICE HAS BEEN RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223516 | V-GO DISPOSABLE INSULIN DELIVERY DEVICE | V-GO | LZG | MANNKIND CORPORATION - V-GO | V-GO 40 | FG423093 | 00385609400018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |