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

Model Number V-GO 40

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

Patient Problems Fall (1848); Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Confusion/ Disorientation (2553)

Event Date 02/21/2014

Event Type  Injury  

Event Description

Pt with type 2 diabetes reported high bg values while wearing v-go insulin delivery device to valeritas call center.Pt reports that while on v-go 40 he was hospitalized on (b)(6) 2014 with dka.As noted by pt's fiancee, on the afternoon of (b)(6) 2014 pt was acting "delirious, confused, falling into things".She then measured his bg at "hi".The fiancee contacted his hcp who recommended 6 clicks (12u) bolus.When bg did not decrease hsp recommended that pt be taken to emergency department (ed).Pt reports the following treatment during hospitalization: at ed, pt bg measured 529 mg/dl; pt was admitted overnight and bg was managed via insulin injection; per patient he was released the next day with bg of approximately 400mg/dl.Pt and fiancee are confident that they applied and used the b-go correctly.Pt confirms that "insulin was going in".Pt denies any current or recent illness, infection, change in diet or exercise or other factors which could cause or contribute to hyperglycemia.Pt confirms that he did deliver his bolus dose of 6 clicks per meal.There is no suggestion of device malfunction.

Manufacturer Narrative

Patient stated that he had been using the product for one day only.Mdr (is being submitted per our procedure since: patient required medical intervention and was hospitalized with diabetic ketoacidosis (dka).No device was returned for investigation so cannot determine whether the hyperglycemia was due to the device not working correctly or due to user error.

Manufacturer Narrative

Block b3- date corrected.Block b4-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; 800 boston turnpike; suite 100; bridgewater NJ 08807 2597
• MDR Report Key: 3678623
• MDR Text Key: 4290831
• Report Number: 1226572-2014-00002
• 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: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2014
• Device Model Number: V-GO 40
• Device Lot Number: FG213117
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 102