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

Model Number V-GO 20

Device Problems Inaccurate Delivery (2339); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 02/28/2014

Event Type  Injury  

Event Description

Type 2 diabetic female pt per physician has been on v-go 20 1-2 weeks.The pt reports she had a blood glucose of 11 mg/dl on (b)(6) 2014 about 9:30am.The pt reports she had just fixed her breakfast, was walking to the parlor and passed out.Her husband found her on the floor and called the rescue squad.The rescue squad removed the v-go.She was treated and hospitalized.In the hospital she indicated she had high blood glucose of 248, 300, and 209 mg/dl.The pt reported she did not use the clicks (mealtime bolus) while using the v-go.She indicated she changed the v-go every day at 8am.When asked if she saw insulin left in the v-go when she removed it she reported there was no insulin left.She reported she had blood glucose of 30, 35, 40, 57, and 63 mg/dl while using the vgo and her symptom was shakiness.The pt indicated she had reported these blood glucose readings to her health care provider.The pt also reported her blood glucose was also 1999 and 300mg/dl while using the v-go.The pt indicated she was checking her blood glucose 4x day and the blood glucose could be any level any time; there was no pattern.The pt indicated there was no differences in lifestyle except she was gaining weight.She reported treating the low blood glucose with orange juice.She reported she ate normally the day before the blood glucose of 11 mg/dl.She reported she often does not take bedtime snack but if she does it is peanut butter and crackers.The pt reported she does not know her aic.The pt reports pre-vgo she was taking 20 units of lantas twice a day and novolog of 10 units twice a day.She indicated she took the same oral medications pre-vgo and when using the vgo of 15mg of actos in the am, glipizide 10mg twice a day and metformin 500 mg twice a day.Pre-vgo the pt reports her blood glucose range was 200-500mg/dl.She reported the lowest blood glucose she ever had pre-vgo was 82mg/dl without symptoms.

Manufacturer Narrative

Procedure requires filing an mdr based on the following info: pt had blood glucose reading level of 11mg/dl.Pt passed out and was unable to recognize and treat the event without third party intervention.Pt was hospitalized.Device was not available for investigation so no contributory cause could be identified for the low blood glucose reading.

Manufacturer Narrative

Block e1- initial reporter corrected.Block e2- health professional - no checked.Block e3- non healthcare professional.Block g4- date provided.Block g7- follow up #1.Block h2- correction checked.Block h6 - patient, device method and conclusion codes corrected.

• Brand Name: V-GO DISPOSABLE INSULIN DELIVERY DEVICE
• Type of Device: V-GO
• Manufacturer (Section D): VALERITAS, LLC; 750 route 202 s; ste 100; bridgewater NJ 08807 2597
• MDR Report Key: 3697644
• MDR Text Key: 4267882
• Report Number: 1226572-2014-00004
• 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: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V-GO 20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR