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 Hypoglycemia (1912)

Event Date 10/07/2014

Event Type  Injury  

Event Description

It was reported to valeritas customer care by type 2 diabetic pt that he had experienced hypoglycemic events with the lowest blood glucose reading of 17 while using the v-go.Pt has been using v-go therapy for one year.Hcp has changed the pt from v-go 30 to v-go 40.Pt stated that there were times of low bg readings where he self medicated by eating peanut butter, milk, and orange juice.Pt also stated "he has had low readings of 17-24-25-27-33 and he said when it was 17 and 24 his wife called 911 and he came aware when he was in an ambulance with "police around him".Pt has also stated that his hcp is aware of these incidents.Valeritas ae assessors have tried to contact the pt to investigate further, without success.Valeritas product compliance has sent a letter to the pt requesting contact info, via (b)(6).

Manufacturer Narrative

This mdr is being submitted following our procedure: pt reported hypoglycemic event with bg reading as low as 17 which required third party intervention to treat; device unavailable for investigation; insufficient info available to explain if v-go contributed to the event or not.

Manufacturer Narrative

Date corrected.Date corrected.Correction #2.Correction checked.

Manufacturer Narrative

Block e2: health professional - no checked; block e3: non-healthcare professional; block g7: follow-up #1; block h1: serious injury; block h2: correction checked.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Type of Device: V-GO
• Manufacturer (Section D): VALERITAS, INC; 750 route 202 south, suite 100; bridgewater NJ 08807 2597
• MDR Report Key: 4203707
• MDR Text Key: 4982145
• Report Number: 1226572-2014-00014
• 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,Followup
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2016
• Device Model Number: V-GO 40
• Device Lot Number: VG313022
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 104