• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VALERITAS, INC. V-GO DISPOSABLE INSULIN DELIVERY DEVICE Back to Search Results
Model Number V-GO 30
Device Problem Appropriate Term/Code Not Available
Event Date 05/24/2019
Event Type  Malfunction  
Event Description

The patient's spouse reported the patient had high blood sugar. It was at its worst today. The patient measured a 445 blood sugar reading while i was talking to her spouse. This was at 12:40pm central time. A normal range for the patient is 190 to 200. It was first noticed yesterday at about 10pm when she measured a 300. At that time she measured her blood sugar because she noticed the start button had released prior to the completion of the 24-hour period. It was put on at about 10am so it was on for 12 hours when it released early. I asked if she had accidentally pressed the needle release button. The patient's spouse said he did not know why it happened. A new v-go was put on at that time. The patient's spouse said his wife did not have any symptoms from the high blood sugar.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameV-GO DISPOSABLE INSULIN DELIVERY DEVICE
Type of DeviceV-GO
Manufacturer (Section D)
VALERITAS, INC.
293 boston post road west
suite 330
marlborough MA 01752
Manufacturer (Section G)
VALERITAS, INC.
293 boston post road west
suite 330
marlborough MA 01752
Manufacturer Contact
scott huie
293 boston post road west
suite 330
marlborough , MA 01752
9089279920
MDR Report Key8746922
Report Number1226572-2019-00125
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 05/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberV-GO 30
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-