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

Model Number V-GO 30

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

Patient Problems Hyperglycemia (1905); Vomiting (2144); Malaise (2359); Diabetic Ketoacidosis (2364); Test Result (2695)

Event Date 03/06/2014

Event Type  Injury  

Event Description

Diabetic patient type 1 per pt.On v-go 30 using novolog reported to valeritas customer care (vcc) high blood glucose readings and was reportedly hospitalized in icu for 4 days.The pt.Indicated he was initially switched from the vgo 20 to the vgo 30 because he was experiencing hyperglycemia.The pt's aic test was around 7 percent pre-v-go and rose to 9 percent he reported in j(b)(6) while using the v-go.The pt reported he was hospitalized with a diagnosis of diabetic ketoacidosis (dka) on (b)(6) 2014 and released on (b)(6) 2014.Blood glucose had risen to 500-600s.He was readmitted (b)(6) 2014 and again released on (b)(6) 2014.Blood glucose had risen to the 400's.The patient reported to valeritas adverse event assessor that the gray indicator on the v-gos hwe used had moved as far as possible indicating the insulin was delivered by the vgo.The pt.Had experienced vomiting and feeling poorly.His white blood count was 19,000 but the hospital tests could not find any infection his wife indicated.The pt's health care provider indicated to the pt.The only explanation they had for the hyperglycemia and dka was the vgo was not delivering insulin.

Manufacturer Narrative

Procedure requires filing and mdr based on the following information: cases involving ketoacidosis unless there is a clear explanation not involving the device.Three devices were returned for investigation.All three devices show no evidence of malfunction.There is evidence that the devices had insulin in them although it could not be determined whether the devices had been completely filled with insulin.Therefore, there was no clear explanation for the dka.See scanned pages.

Manufacturer Narrative

Block b3- date corrected, 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 h1- serious injury, 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 south; ste 600; bridgewater NJ 00807 2597
• MDR Report Key: 3750755
• MDR Text Key: 4554988
• Report Number: 1226572-2014-00005
• 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: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2014
• Device Model Number: V-GO 30
• Device Lot Number: VG312060
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2014
• Date Manufacturer Received: 03/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR