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

Model Number	V-GO 40
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient stated that from his most recent v-go box he experience the needle button popping out before 24 hours on two of his v-go's.Patient stated that just when he was about to give himself his bolus clicks patient noticed that that the needle button popped out.Patient stated that he is applying the vgo device on his abdomen.
Additional Manufacturer Narrative
Two devices were returned and evaluated.The evaluation results are as follows: the complaint about the needle button released event could not be determined.The device was returned with the needle release button depressed, due to this condition, it is not possible to determine if the needle button had unintentionally retracted during use.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Common Device Name: V-GO
• Manufacturer (Section D): ZEALAND PHARMA U.S. INC.; 293 boston post road west; suite 330; marlborough MA 01752
• MDR Report Key: 10971590
• Report Number: 1226572-2020-00467
• Device Sequence Number: 14526770
• Product Code: LZG
• UDI-Device Identifier: 00385609600012
• UDI-Public: (01)00385609600012(17)230618(10)FG420167
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/07/2020

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: No Information
• Device Expiration Date: 06/18/2023
• Device Model Number: V-GO 40
• Device Catalogue Number: 8560-9600-01
• Device Lot Number: VG420109B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR