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

Model Number	V-GO 20
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported the needle came out of his body and the device fell off his abdomen after wearing it for 11 hours.The patient did not experience any symptoms.The patient stated there was no increased movement or interference from his clothing when the v-go fell off.The patient prepares the abdomen for a v-go with an alcohol wipe and lets it dry before applying a v-go.The patient tries to avoid areas that have excess skin, muscle, bone, scars, and removes hair from the area were patient applies the devices.

• 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; suite330; marlborough MA 01752
• MDR Report Key: 12127701
• Report Number: 1226572-2021-00253
• Device Sequence Number: 11966259
• Product Code: LZG
• UDI-Device Identifier: 00385609600036
• UDI-Public: (01)00385609600036(17)230628(10)FG220220
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

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: 06/28/2023
• Device Model Number: V-GO 20
• Device Catalogue Number: 8560-9600-03
• Device Lot Number: VG220115B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 105