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	06/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The patient's mother called to report that her son has had v-gos dropping off his upper arm after about six hours on average.The reporter stated it happened with four devices from the same box an this is the first batch this has happened with.The first one was about a week ago and two came off yesterday.The patient's mother said it may be due to sweating, but also she thinks it may have been a problem with the adhesive.She said this has not happened before.The v-go's were all thrown out.

• 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: 10214805
• Report Number: 1226572-2020-00228
• Device Sequence Number: 3232974
• Product Code: LZG
• UDI-Device Identifier: 00385609600012
• UDI-Public: (01)00385609600012(17)221113(10)FG420090
• 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): 06/30/2020

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: 11/13/2022
• Device Model Number: V-GO 40
• Device Catalogue Number: 8560-9600-01
• Device Lot Number: VG419292B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR