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

Model Number V-GO 40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/02/2013

Event Type  Death  

Event Description

It was reported to valeritas customer care during an inbound call on (b)(6) 2014 to the pt's wife who had just started on the v-go that her husband who had also been on the v-go had passed away on (b)(6) 2013.Pt was a type 2 diabetic and was on the v-go 40 for 4 months prior to passing away.She did not indicate the cause of death.Pt's wife declined to offer further info to valeritas customer care.It is unk if the v-go or diabetes was involved in this pt's death.It is not possible to assess contributory factors to this pt's death without further details and info.The adverse event assessor made multiple attempts to contact the pt's family to further investigate.Results have not been fruitful.

Manufacturer Narrative

This mdr is being submitted following our procedure: pt expired (reportable event) while on the v-go; device unavailable for investigation; insufficient info available to explain if v-go contributed to the event or not.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Type of Device: V-GO
• Manufacturer (Section D): VALERITAS, INC.; 750 route 202 s; ste 100; bridgewater NJ 08807 2597
• Manufacturer Contact: scott huie ; 800 boston turnpike; shrewsbury, MA 01545
• MDR Report Key: 4115801
• MDR Text Key: 15997703
• Report Number: 1226572-2014-00010
• Device Sequence Number: 1
• Product Code: KZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• 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
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 58 YR