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 Codes	Bruise/Contusion (1754); Pain (1994)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Adverse event (ae) assessment: ae assessor spoke with the vgo 30 user.She states that she has had several devices in which the needle pops out before 24 hours.She tries to make the device last by pushing the needle back in.She states this is painful and causes bruising.She denied any signs of infection.She does not prep the skin with alcohol prior but will start to do so.She denies placing the device over scar tissue or skin folds.She does wear the device on her abdomen.She prefills the devices with two weeks' worth of devices and stores them in the refrigerator.She was instructed not to prefill.This is a device complaint which caused a non-serious ae related to skin pain and bruising.Pain and bruising are expected side effects when a needle is used.
Event or Problem Description
The patient reported they are having issues with the needle of their v-go not staying in (releasing).The patient reported the issue is causing them pain and bruising.The patient stated they must hold the device for the insulin to release which causes pain.The device was reported to be available for return to the manufacturer for evaluation, however to date has not been received.
Additional Manufacturer Narrative
Device evaluation: fifteen devices were received and evaluated for the needle button released event complaint.All devices were received, and the needle mechanism functions were tested and verified to have operated as intended.The complaint could not be confirmed for these devices.

• 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: 16272886
• Report Number: 1226572-2023-00004
• Device Sequence Number: 18030959
• Product Code: LZG
• UDI-Device Identifier: 00385609600029
• UDI-Public: (01)00385609600029(17)241108(10)FG322037
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/11/2023

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: 01/08/2025
• Device Model Number: V-GO 30
• Device Catalogue Number: 8560-9600-02
• Device Lot Number: VG322004C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2022
• 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: 66 YR
• Patient Sex: Female