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

Model Number	V-GO 40
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated.The evaluation results are as follows: the complaint about the adhesive pad issue could not be confirmed.The device showed some adhesion on the foam pad and no abnormalities that could contribute to the reported event.Due to the used condition of the adhesive pad, the original adhesion properties could not be verified.
Event or Problem Description
The patient reported that he noticed that the v-go was coming loose from his skin.The patient had the v-go applied to his abdomen and stated that all the sweat from working outside loosened the adhesiveness.

• 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
• MDR Report Key: 10308908
• Report Number: 1226572-2020-00226
• Device Sequence Number: 804616
• Product Code: LZG
• UDI-Device Identifier: 00385609600012
• UDI-Public: (01)00385609600012(127)220917(10)FG419232
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2020

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: Lay User/Patient
• Device Expiration Date: 09/17/2022
• Device Model Number: V-GO 40
• Device Catalogue Number: 8560-9600-01
• Device Lot Number: FG419232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR