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

Model Number	V-GO 20
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was created by (b)(6), device vigilance specialist of zealand pharma us, inc.On behalf of the mannkind, corp.As part of the acquisition and subsequent transfer of the v-go medical device to the latter organization.This temporary transition activity is expected to continue until such time that the acquiring company establishes its own mdr reporting account.
Event or Problem Description
The patient reported that the last 3 v-go 20 devices have fallen off of her stomach and it does not seem like the adhesive has enough glue.The patient stated that with the previous batch, there was too much glue and the v-go 20 devices were sticking too tightly causing it to hurt when pulling them off.The patient confirmed that she uses an alcohol swab to clean the infusion site prior to applying the v-go.The patient stated that the last v-go fell on the floor while she was getting up which was almost at 24 hours of use.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Common Device Name: 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: 14806043
• Report Number: 1226572-2022-00088
• Device Sequence Number: 14625190
• Product Code: LZG
• UDI-Device Identifier: 00385609600036
• UDI-Public: (01)00385609600036(17)240805(10)FG221166
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K103825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/05/2024
• Device Model Number: V-GO 20
• Device Catalogue Number: 8560-9600-03
• Device Lot Number: VG221074C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female