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

Model Number	V-GO 30
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported that with their recent box of v-go 30, the needle pops out prematurely which is painful.The patient tried to push the needle back in and that did not work.It was reported that devices are available for return to the manufacturer for evaluation.However, to date, have not been received.
Additional Manufacturer Narrative
Adverse event (ae) assessment: the ae assessor was unable to reach the patient after multiple attempts.A patient may experience temporary pain from needle contact with the skin when needle pops out prematurely or needle release button does not release the needle.This is not a serious event.
Additional Manufacturer Narrative
Device evaluation: five devices were received and evaluated for the needle button released event.The devices were inspected, and the needle mechanism functions were tested and verified to have operated as intended.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: 22009627
• Report Number: 1226572-2025-00008
• Device Sequence Number: 17450339
• Product Code: LZG
• UDI-Device Identifier: 00385609400025
• UDI-Public: (01)00385609400025(17)251228(10)FG323026
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: 01/02/2026
• Device Model Number: V-GO 30
• Device Lot Number: VG323001C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2023
• 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 Sex: Female