MAUDE Adverse Event Report: MANNKIND CORPORATION - V-GO V-GO DISPOSABLE INSULIN DELIVERY DEVICE

Model Number V-GO 20

Device Problem Premature Separation (4045)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 03/20/2023

Event Type  malfunction  

Event Description

The patient reported that two v-go 20 devices were only staying on by the needle when she got out of the shower.It was loose on the sides as adhesive was not there and the device remained intact with the needle still attached to her body.Also, the patient reported they are getting very red itchy patches where she applies the v-go.The patient's healthcare practitioner (hcp) orders skin-tac wipes for allergic reaction to the adhesive.The patient was wondering if the adhesive has changed.She has been on v-go for 5 years and does not want to quit using it.Additional information received from adverse event assessment revealed the patient had two devices fall off in the shower.It was reported there was no device available for return to the manufacturer for evaluation.

Manufacturer Narrative

Adverse event (ae) assessment: ae assessor spoke with this long-term v-go 20 user.The patient reported she has been very happy with the device.Recently she started to develop skin rashes where the device is placed.She rotates sites between her arms and her abdomen.She states the rash is red, itchy, and sometimes raised like a hive.She denies any signs of infection.She states she does have a history of other allergies.Her hcp recommended skin tac barrier wipes, but she said they don't really work.She will try out the cavilon barrier wipes when she gets them.The hcp recommended she try flonase, which she has not used yet.She mentioned that she thinks the adhesive layer is thinner than in the past.She has had two devices come off in the shower and has never had that happen before.The v-go uses medical grade hypoallergenic adhesive, but some people may develop a reaction.This is not a serious adverse event, but it is possible the device contributed.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Type of Device: V-GO
• Manufacturer (Section D): MANNKIND CORPORATION - V-GO; 293 boston post road w; #330; marlborough MA 01752
• Manufacturer (Section G): MANNKIND CORPORATION - V-GO; 293 boston post road w; #330; marlborough MA 01752
• Manufacturer Contact: jeffrey zajac ; 293 boston post road w; #330; marlborough, MA 01752
• MDR Report Key: 16707620
• MDR Text Key: 312978783
• Report Number: 1226572-2023-00025
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 00385609400032
• UDI-Public: (01)00385609400032(17)250309(10)FG222057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V-GO 20
• Device Catalogue Number: 8560-9400-03
• Device Lot Number: FG222057
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female