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

Model Number	V-GO 20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adverse event (ae) assessment: ae assessor contacted type 2 diabetes mellitus (dm), v-go 20, novolog insulin patient for 3 years.Spoke with patient and spouse.The patient is reporting that the bolus button did not work she was not receiving the insulin.For this case she is reporting that the bolus button was stuck, did not move.She reports elevated blood sugar readings 500 after wearing the device for only a few hours and bolus button did not work, it was stuck.She denies using all bolus clicks and recalls it may have been the first clicks she tried for the device.She does recall the ready start button was pressed and it did click.The patient was alerted elevated blood sugar, tried to give bolus clicks and the button was stuck and did not work.Since this has happened before she knew she was not receiving the insulin.She removed the v-go device, applied new device and gave additional insulin.Blood sugars started to decline to normal range.No additional medical treatment or follow-up was needed.While wearing the device she denies any leaking or release of the needle start button.When removed, the device was filled with insulin.A blood glucose reading 400 or greater is considered serious.Client reported blood glucose 500, can be serious with recurrence.
Event or Problem Description
The patient reported that their v-go suddenly stopped dispensing insulin when they clicked the bolus button and caused hyperglycemia.No additional information was provided at intake.It was reported that the device is available for return to the manufacturer for evaluation.However, to date, has not been received.
Additional Manufacturer Narrative
Device evaluation: one device was received and evaluated for the bolus button locked out < 18 clicks complaint.Device#: 053294-a was inspected, and the bolus mechanism was verified to have operated as intended.The complaint about this device in relation to the report of hyperglycemia 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: 18595829
• Report Number: 1226572-2024-00003
• Device Sequence Number: 6660154
• Product Code: LZG
• UDI-Device Identifier: 00385609400032
• UDI-Public: (01)00385609400032(17)250321(10)FG222063
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/23/2025
• Device Model Number: V-GO 20
• Device Lot Number: VG222028C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female