FDA Adverse Event
Malfunction
Summary report: N
V-GO DISPOSABLE INSULIN DELIVERY DEVICE
MDR report key: 18291470
·
Received December 8, 2023
Report
- Report Number
- 1226572-2023-00134
- Event Type
- Malfunction
- Date Received
- December 8, 2023
- Date of Event
- November 19, 2023
- Report Date
- November 20, 2023
- Manufacturer
- MANNKIND CORPORATION - V-GO
- Product Code
- LZG
- PMA / PMN Number
- K103825
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
DEVICE EVALUATION: ONE DEVICE WAS RECEIVED AND EVALUATED FOR THE DEVICE FELL OFF COMPLAINT. DEVICE #053228-A WAS INSPECTED AND FUNCTIONAL TESTS WERE PERFORMED. THE ADHESIVE PAD WAS PROBED, AND IT VERIFIED THAT THERE WAS A MODERATE AMOUNT OF ADHESION REMAINING. THE DEVICE ASSESSMENT VERIFIED THAT THE FOAM PAD ADHESION STRENGTH WAS ACCEPTABLE. DUE TO THE CONDITION OF THE FOAM PAD, THE ORIGINAL ADHESIVE PROPERTIES COULD NOT BE VERIFIED. THE COMPLAINT ABOUT THIS DEVICE COULD NOT BE CONFIRMED.
Description of Event or Problem · 0
THE PATIENT REPORTED THAT ONE OF THEIR V-GO 20S CAME OFF DUE TO THE ADHESIVE GETTING LOOSE AND NOT STICKING. THE DEVICE WAS REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212226 | V-GO DISPOSABLE INSULIN DELIVERY DEVICE | V-GO | LZG | MANNKIND CORPORATION - V-GO | V-GO 20 | FG223033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male |