FDA Adverse Event
Malfunction
Summary report: N
V-GO DISPOSABLE INSULIN DELIVERY DEVICE
MDR report key: 9298613
·
Received November 8, 2019
Report
- Report Number
- 1226572-2019-00529
- Event Type
- Malfunction
- Date Received
- November 8, 2019
- Date of Event
- October 23, 2019
- Report Date
- October 30, 2019
- Manufacturer
- VALERITAS, INC.
- Product Code
- LZG
- UDI-DI
- 00385609600012
- PMA / PMN Number
- K103825
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED AND EVALUATED. THE EVALUATION RESULTS ARE AS FOLLOWS: THE 3 V-GO COMPLAINTS FOR THE NEEDLE BUTTON RELEASED COULD NOT BE DETERMINED AS THE COMPLAINT COULD NOT BE CONFIRMED.
Description of Event or Problem · 1
THE PATIENT'S SPOUSE REPORTED THAT ABOUT FOUR V-GOS OUT OF THE SAME BOX HAD PROBLEMS WITH EITHER THE START BUTTON WOULD NOT DEPRESS OR IT WOULD GO IN BUT WOULD NOT STAY IN. PATIENT SPOUSE SAID SHE HAS TWO OF THOSE V-GOS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1092624 | V-GO DISPOSABLE INSULIN DELIVERY DEVICE | V-GO | LZG | VALERITAS, INC. | V-GO 40 | VG419048B | 00385609600012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |