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

Model Number V-GO 40

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abscess (1690); Erythema (1840); Pain (1994)

Event Date 07/18/2014

Event Type  Injury  

Event Description

It was reported to valeritas customer care that diabetic patient (pt).Type 2 using the v-go 40 since (b)(6) 2014 experienced an abscess on his abdomen while using the v-go.According to the valeritas adverse event (ae) assessor, the patient stated that on (b)(6)2014, he removed the v-go from his left abdominal area, noticed a red mark and after a few days the red mark became "much larger, was hot, hard and very painful to touch".Patient reports he went to the emergency room on (b)(6) 2014, the abscess was drained and packed.Patient was not hospitalized.Patient states the drainage is still continuing (patient was not able to describe drainage amount or color), the site is very red and tender, the size of silver dollar.Patient was given a prescription and instructed to start antibiotics immediately (name of antibiotic unknown by patient), however patient has not filled the antibiotic prescription and states he will not be able to start the antibiotic till (b)(6) 2014 due to financial reasons.Ae assessor instructed patient to contact his hcp right away to discuss with hcp that he has not started the antibiotic.Patient is currently off the v-go for financial reasons, he was not discontinued from v-go by hcp.

Manufacturer Narrative

This mdr is being submitted per our procedure.Patient experienced an adverse event in the form of an abscess (on abdomen) at application site.Patient went to the emergency room where the abscess was drained and packed (medical intervention) to prevent further complications.The device was not available for investigation.Even though the v-go is terminally sterilized, there is always the possibility of infection at the application site and site preparation.Diabetics are also prone to infection.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Type of Device: V-GO
• Manufacturer (Section D): VALERITAS, LLC.; 750 route 202 south; suite 100; bridgewater NJ 08807 2597
• MDR Report Key: 4036900
• MDR Text Key: 4726007
• Report Number: 1226572-2014-00008
• Device Sequence Number: 1
• Product Code: KZE
• Combination Product (y/n): N
• PMA/PMN Number: K103825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Type of Report: Initial,Followup
• Report Date: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V-GO 40
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 102