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

Model Number	V-GO 30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported he went to his local urgent care center on (b)(6) 2019 and was told he had an infection at the reported vgo site.Patient was given oral antibiotics for the infection - amoxicillin.

• 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: 9506981
• Report Number: 1226572-2019-00595
• Device Sequence Number: 19158661
• Product Code: LZG
• UDI-Device Identifier: 00385609600029
• UDI-Public: (01)00385609600029(17)220218(10)FG319155
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K103825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/18/2022
• Device Model Number: V-GO 30
• Device Catalogue Number: 8560-9600-02
• Device Lot Number: VG319095B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 91