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

Model Number	V-GO 30
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	01/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A v-go trainer called to report that a patient stated that their v-go had fallen off and they did not have any insulin for four days.The patient was then hospitalized with high blood sugar.Additional information received from the patient stated that they were hospitalized from (b)(6) 2025 to (b)(6) 2025 due to high blood sugar levels/diabetic ketoacidosis (dka).The patient put his v-go on in the morning around 9am and left his home.His sugars started going out of range and in addition to his heart issue, he had to go to the hospital.The v-go was not delivering insulin, and the patient did not have any backup insulin outside the house.Patient also stated that v-go does not suit his very active lifestyle.No devices are available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Adverse event (ae) assessment: ae assessor was unable to contact patient after multiple attempts.Information available was obtained from trainer and follow-up from patient.Patient with reported type 1 diabetes, using the v-go 30 for 2 months, type of insulin unknown, was hospitalized due to high blood sugars dka.The patient reports putting on a v-go at 9 am and left home.His blood sugars increased out of range and addition to his heart issue had to go to the hospital.The v-go was not delivering insulin and he did not have any back up insulin outside the house.The v-go device is not available for collection.Per trainer the patient stated the v-go had fallen off and the patient did not have insulin for 4 days and was hospitalized for high blood sugar.Additional details and timeline for this case is unknown.Unable to conclude if the device fell off or device stopped delivering insulin that resulted in elevated blood glucose readings and diagnosis dka.No blood sugar readings were reported; except elevated and dka.If the device did not fall off and stopped delivering insulin it is possible the v-go device contributed to the reported elevated blood glucose readings, hospitalization of dka.If the device fell off, patient was aware and there was a 4-day delay of insulin management, it is unlikely related to the v-go device.Elevated blood sugars and diagnosis of dka is a serious event.

• 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: 21349262
• Report Number: 1226572-2025-00002
• Device Sequence Number: 7854423
• Product Code: LZG
• UDI-Device Identifier: 00385609400025
• UDI-Public: (01)00385609400025(17)260911(10)FG324018
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/11/2026
• Device Model Number: V-GO 30
• Device Lot Number: FG324018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male