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

Model Number	V-GO 30
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported 6 times the v-go devices fell off.The patient uses alcohol wipes and lets it dry prior to using v-go.The patient avoids placing v-go in areas of her body containing excess skin, muscle, and bone.The patient did not have any interference with her clothing.The patient is unsure how long she wore the devices prior to them coming off besides the one time it came off around noon and the patient noticed her blood sugar went high.The patient explained when that occurred patient started to feel cold, cooled, and kind of sluggish.

• 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
• Manufacturer (Section G): ZEALAND PHARMA U.S. INC.; 293 boston post road west; suite330; marlborough MA 01752
• Manufacturer Contact: liliana hansen ; 293 boston post road west; suite330; marlborough, MA 01752
• MDR Report Key: 13805139
• Report Number: 1226572-2022-00028
• Device Sequence Number: 4994365
• Product Code: LZG
• UDI-Device Identifier: 00385609600029
• UDI-Public: (01)00385609600029(17)240610(10)FG321156
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2022

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: 06/10/2024
• Device Model Number: V-GO 30
• Device Catalogue Number: 8560-9600-02
• Device Lot Number: VG321083C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female