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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/7, the patient had 2 v-go 30 devices fall off -- one that was applied for 2 hours between 8am-10 and another that fell off after 5 hours between 10am and 3pm.The patient mentioned that he could feel the needle sticking in and out when the v-go 30 became loose.The patient confirmed that he has been using an alcohol swab prior to applying the v-go 30 devices and stated that the v-go devices have fallen off patient stomach, arm, hip and shoulder.
Additional Manufacturer Narrative
Two devices were returned and evaluated.The evaluation result is as follows: two devices were received and evaluated for the complaint regarding the device fell off event.All device functions were inspected, and no issue was observed.Due to the used condition of the foam pad, the original adhesion properties could not be verified.The complaint for these devices could not be confirmed.

• 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: 13859931
• Report Number: 1226572-2022-00021
• Device Sequence Number: 13820046
• Product Code: LZG
• UDI-Device Identifier: 00385609600029
• UDI-Public: (01)00385609600029(17)240610(10)FG321156
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2022

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
• Device Expiration Date: 06/10/2024
• Device Model Number: V-GO 30
• Device Catalogue Number: 8560-9600-02
• Device Lot Number: VG321082C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 70 YR
• Patient Sex: Male