MAUDE Adverse Event Report: VALERITAS, INC. V-GO DISPOSABLE INSULIN DELIVERY DEVICE

Model Number	V-GO 30
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient reported that since (b)(6) 2019 the first day under v-go therapy, the device keeps coming loose from her body.In the first day the patient put the device on at 11:00 a.M.And at 7:00 p.M.The device came loose from patient skin.In the second day, patient put the device at 11:00 a.M.And the device came loose from patient skin at 5:00 p.M.Patient sweats a lot.There was no extra movements or exercise was performed while using the device, no interference with clothing.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Common Device Name: V-GO
• Manufacturer (Section D): VALERITAS, INC.; 293 boston post road west; suite 330; marlborough MA 01752
• MDR Report Key: 9297689
• Report Number: 1226572-2019-00520
• Device Sequence Number: 16245733
• Product Code: LZG
• UDI-Device Identifier: 00385609600029
• UDI-Public: (01)00385609600029(17)211108(10)FG319091
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2019

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: 11/08/2021
• Device Model Number: V-GO 30
• Device Catalogue Number: 8560-9600-02
• Device Lot Number: FG319091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 89