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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: one device was received and evaluated for the needle button released event complaint.The device was inspected, and the needle mechanism functions were tested and verified to have operated as intended.The complaint about this device could not be confirmed.
Event or Problem Description
The patient reported that the start button of their v-go pushes out (releases) during the day while they are still wearing the device.The patient reported that this occurred three times with the same box.Specific event dates were not provided.It was reported that a device is available for return to the manufacturer for evaluation.

• 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: 20023483
• Report Number: 1226572-2024-00045
• Device Sequence Number: 7448518
• Product Code: LZG
• UDI-Device Identifier: 00385609400025
• UDI-Public: (01)00385609400025(17)250214(10)FG322043
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/30/2024

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: 02/14/2025
• Device Model Number: V-GO 30
• Device Lot Number: FG322043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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: 63 YR
• Patient Sex: Male