Events

Alerte Ou Avis De Sécurité sur NordiPen® used with 5mg and 10mg Norditropin® SimpleXx® (‘somatropin’) and NordiPenMate®

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Novo Nordisk.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2013/071
  • Numéro de l'événement
    CON314666
  • Date
    2013-09-05
  • Date de publication de l'événement
    2013-09-05
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON314666?tabName=allTabs
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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®
  • Modèle / numéro de série
  • Description du dispositif
    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