MAUDE Adverse Event Report: ZEALAND PHARMA U.S. INC. V-GO DIDPOSABLE INSULIN DELIVERY DEVICE

Model Number	V-GO 20
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Adverse event assessor(aea) stated that the patient reported the aea that the needle button did not stay locked.The patient reported that the event happened on (b)(6) 2021 at 8:00am the patient locked the needle button and between 2:00-2:30pm, it was unlocked.The aea indicated that the patient mentioned that she did hear the click, pressed the needle button on the rounded tip.The patient mentioned that she was not getting the insulin her body needed.The patient stated that she did not click the needle release button, by error.

• Brand Name: V-GO DIDPOSABLE INSULIN DELIVERY DEVICE
• Common Device Name: V-GO
• Manufacturer (Section D): ZEALAND PHARMA U.S. INC.; 293 boston post road west; suite330; marlborough MA 01752
• MDR Report Key: 12283478
• Report Number: 1226572-2021-00303
• Device Sequence Number: 14445717
• Product Code: LZG
• UDI-Device Identifier: 00385609600036
• UDI-Public: (01)00385609600036(17)230608(10)FG220219
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/15/2021

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: 06/08/2023
• Device Model Number: V-GO 20
• Device Catalogue Number: 8560-9600-03
• Device Lot Number: VG220104B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 105