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

Model Number	V-GO 20
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported that they are losing their v-go's.Upon clarification the patient stated that the v-go's are falling off five to six times.The patient alternates placement on the left and right side of the abdomen.There is no device available for return to the manufacturer for evaluation.Upon follow-up it was reported that the patient experienced hyperglycemia.
Additional Manufacturer Narrative
Adverse event (ae) assessment: ae assessor contacted type 2 diabetes mellitus (dm) v-go 20, novolog insulin user for the past 1 month.Client reported the v-go device has fallen off 5 or 6 times in the past month.Client reports following v-go manual procedure for skin preparation and wipes with alcohol pad prior to applying the device.The device is applied to the abdomen, flat area, avoiding the bend/waistline and there is no hair on the skin.Placement rotates daily from left to right side of abdomen.Adhesion tape surface area is pressed firmly with fingers along all sides.The device is applied in the morning.Length of time the device was worn prior to falling off varies.Client works in an air-conditioned environment.Client denies sweating, moisture, exposure to water or bumping the device.Sometimes the client was aware when the device fell of when poked or pinch from the needle.Other times he was unaware when the device fell off.When the device fell off blood glucose readings increased to about 300.When the new v-go device was applied, blood glucose readings returned to normal range.No additional medical treatment was needed.A blood sugar reading of 300 is elevated, but not considered serious.

• 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: 17070621
• Report Number: 1226572-2023-00042
• Device Sequence Number: 6841737
• Product Code: LZG
• UDI-Device Identifier: 00385609400032
• UDI-Public: (01)00385609400032(17)250630(10)FG222103
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: FG222103
• 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): 05/17/2023

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: 06/30/2025
• Device Model Number: V-GO 20
• Device Catalogue Number: 8560-9400-03
• Device Lot Number: FG222103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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: 38 YR
• Patient Sex: Male