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

Model Number V-GO 20

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

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 02/03/2014

Event Type  Injury  

Event Description

Adverse event was reported to valeritas rep by certified diabetes educator who stated that diabetic (type unk) female pt was admitted to the hospital on (b)(6) 2014, with blood glucose over 700mg/dl while wearing the v-go 20 for two weeks.Adverse event assessor has made multiple attempts to obtain additional information without success.

Manufacturer Narrative

Procedure requires filing an mdr based on the following information: pt was hospitalized with blood glucose level of over 700 mg/dl.Minimal info has been obtained in this case due to lack of response from the pt to follow-up calls and letter.No device returned for investigation.No explanation for incident.

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, results 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: 3697617
• MDR Text Key: 14877940
• Report Number: 1226572-2014-00003
• 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: 02/25/2014

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: 02/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 44 YR