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

Model Number	V-GO 40
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient stated since he started using this order around the first of september 6 of the v-go 40s have fallen off prematurely.He stated he has used this product for about 5 years and does not recall this ever happening before.It was reported that the devices are available for return to the manufacturer for evaluation.However, to date, have not been received.
Additional Manufacturer Narrative
Device evaluation: six devices were received and evaluated for the device fell off complaint.All devices were received and inspected; due to the condition of the adhesive foam pad upon receipt, the original adhesion properties could not be verified.The device assessment verified that the foam pad adhesion strength was acceptable.The complaint about these devices could not be confirmed.

• 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: 17860538
• Report Number: 1226572-2023-00111
• Device Sequence Number: 5909067
• Product Code: LZG
• UDI-Device Identifier: 00385609400018
• UDI-Public: (01)00385609400018(17)250723(10)FG422112
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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: 07/23/2025
• Device Model Number: V-GO 40
• Device Lot Number: FG422112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2022
• 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: 66 YR
• Patient Sex: Male