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

Model Number V-GO 20

Device Problem Appropriate Term/Code Not Available

Event Date 05/01/2019

Event Type  Malfunction  

Event Description

Patient informed that one day he experienced the needle button popping out before 24 hours. Patient stated that he does not remember the exact date this occurred.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Type of Device: V-GO
• Manufacturer (Section D): VALERITAS, INC.; 293 boston post road west; suite 330; marlborough MA 01752
• Manufacturer (Section G): VALERITAS, INC.; 293 boston post road west; suite 330; marlborough MA 01752
• Manufacturer Contact: scott huie ; 293 boston post road west; suite 330; marlborough , MA 01752 ; 9089279920
• MDR Report Key: 8746923
• Report Number: 1226572-2019-00123
• Device Sequence Number: 1
• Product Code: LZG
• Report Source: Manufacturer
• Source Type: CONSUMER

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/22/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 06/30/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: V-GO 20
• Device LOT Number: UNKNOWN
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/22/2019
• Was Device Evaluated By Manufacturer?: No
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial