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	Pain (1994)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient's daughter reported that her mom has had 5 v-go devices within the last week that have fallen off patient body.The patient daughter mentioned that they stayed on her mom for approximately 1 to 4 hours and then fell off.The patient is wearing the v-go on the backside of her arm.The patient daughter confirmed that her mom was preparing the infusion site properly by cleaning the area with a alcohol swab and letting the area dry.The patient daughter stated that her mom placed back on 2 v-go devices after it had fallen off and it hurt patient.
Additional Manufacturer Narrative
Device evaluation: five devices were received and evaluated for the complaint regarding the device fell off event.All device functions were inspected.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: 14516146
• Report Number: 1226572-2022-00068
• Device Sequence Number: 15085832
• Product Code: LZG
• UDI-Device Identifier: 00385609600036
• UDI-Public: (01)00385609600036(17)230109(10)FG220129
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: 01/09/2023
• Device Model Number: V-GO 20
• Device Catalogue Number: 8560-9600-03
• Device Lot Number: FG220129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2020
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 75 KG