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	Needle Stick/Puncture (2462)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported that two v-go 40 devices fell off while the patient was sleeping.The patient reported that the needle poked him.It was reported that the devices were 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 unsuccessful in contacting the patient.Information is limited to the initial call.The patient was poked from the exposed needle when the device fell off.No blood sugar readings were shared at a result of the device falling off.No medical follow up is reported from being poked by the exposed needle or the device falling off.

• 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: 20311652
• Report Number: 1226572-2024-00057
• Device Sequence Number: 8883758
• Product Code: LZG
• UDI-Device Identifier: 40385609400016
• UDI-Public: (01)40385609400016(17)260523(10)FG423112
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/06/2024

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: 05/23/2026
• Device Model Number: V-GO 40
• Device Lot Number: FG423112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2023
• 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 Age: 59 YR
• Patient Sex: Male