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

Model Number V-GO 40

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Glaucoma (1875); Hyperglycemia (1905); Skin Irritation (2076)

Event Date 01/08/2014

Event Type  Injury  

Event Description

Patient on v-gu 40 called into the company's customer (b)(4) to report multiple adverse events while wearing v-go.Patient reports that he is a type 2 diabetic and has been on v-go for approximately 3 months.The patient reported that he wears two v-go 40's every 12 hours (off label use).Patient reports: skin irritation, hyperglycemia, laser surgery to correct "diabetic glaucoma." patient reports a "pre-v-go" blood glucose range of 120-150 and a "with v-go" blood glucose range of 82-400.Patient reports that he had outpatient surgery for diabetic glaucoma correction for his left and right eyes.Patient believes that the glaucoma may be related to hyperglycemia and blood glucose variability while wearing v-go.

Manufacturer Narrative

The devices were not returned for investigation, so unable to confirm any device malfunction.Patient was using two v-go's at the same time (off label usage) which indicates a large insulin requirement and therefore prone to hyperglycemia.Patient reports wide variation in bg levels when using the device.Chronic hyperglycemia can cause an increase in ocular pressure (glaucoma) which, if left untreated, can lead to blindness (serious injury).In this case, the patient required medical treatment (laser surgery).Since the patient required medical intervention (laser surgery) for treatment of a potentially serious adverse event and there was no attributable cause (due to device not being returned) a mdr is being submitted.

• 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: 3641092
• MDR Text Key: 21110829
• Report Number: 1226572-2014-00001
• 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: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 66 YR
• Patient Weight: 104