Events

Safety Alert Or Field Safety Notices for NordiPen® used with 5mg and 10mg Norditropin® SimpleXx® (‘somatropin’) and NordiPenMate®

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Novo Nordisk.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/071
  • Event Number
    CON314666
  • Date
    2013-09-05
  • Event Date Posted
    2013-09-05
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON314666?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
  • Reason
    There is a risk of under-dosing as the device may not fully screw together. a change to the metal screw threads of the mechanical section may cause the user to experience increased resistance during assembly.  patients may assume the pen is correctly assembled when it is not, and therefore not receive the correct dose. the manufacturer issued field safety notice (fsn) in july and september 2013 advising users of the problem and how to assemble the devices; however, they have received insufficient reconciliation data.
  • Action
    Ensure that all staff who are responsible for managing patients with these devices are aware of the assembly instructions in the FSNs. Identify all patients who use these devices and ensure that they receive the patient letter attached to either FSN explaining how to assemble the devices. Return the confirmation of receipt form in the FSNs to the manufacturer.

Device

NordiPen® used with 5mg and 10mg Norditropin® SimpleXx® (‘somatropin’) and NordiPenMate®
  • Model / Serial
  • Product Description
    Growth hormone pens. NordiPen® used with 5mg and 10mg Norditropin® SimpleXx® (‘somatropin’) and NordiPenMate®. NordiPen® NordiPenMate® All devices with a lot number beginning with A or B. Lot numbers beginning with a ‘C’ are referred to in the July 2013 FSN but they were never distributed by the manufacturer. How to find the lot number The lot number is located on the mechanical section below the push button and can be exposed by turning the dose selector clockwise. The lot number in the example image begins with ‘B’.
  • Manufacturer
    Novo Nordisk

Manufacturer

Novo Nordisk