Events

Alerte Ou Avis De Sécurité sur Animas® IR 1200, Animas® 2020, One Touch® Ping® Glucose management system, Animas® Vibe™

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 manufacturer #17429.

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/2012/059
  • Numéro de l'événement
    CON180652
  • Date
    2012-08-22
  • Date de publication de l'événement
    2012-08-22
  • 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/CON180652?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
    Risk of compromised insulin therapy due to failure of the buttons caused by keypad wear. the manufacturer has noted an increase in customer complaints regarding the durability of the insulin pump keypad. deterioration has led to the coating tearing and the edge of the keypad peeling away from the pump. there are also reports of the keys becoming unresponsive or sticking. animas has consequently redesigned the keypad to improve durability. the manufacturer has found that the average time to failure is 18 months. animas distributed a patient notification letter on the 16 july 2012 (see appendix). there is updated information on the animas website (external link).
  • Action
    Check the list of serial numbers affected in the Animas UK document. Ensure that patients using the pump are aware of: the potential for buttons to fail. the need to examine the keypad regularly for signs of wear, such as peeling or tearing of the keypad edge from the pump. the need to have a back-up insulin delivery method available at all times. Patients and healthcare providers should refer to the updated Animas patient information in the appendix. Patients who identify problems with, or have concerns about, their pump’s keypad should contact their health care provider and Animas customer technical support. Report any problems with the pump to the MHRA. Diabetes departments. Pharmacists. Those involved in procurement, supply and use of this device.

Device

Animas® IR 1200, Animas® 2020, One Touch® Ping® Glucose management system, Animas® Vibe™
  • Modèle / numéro de série
  • Description du dispositif
    Animas ambulatory insulin infusion pumps. Animas® IR 1200 Animas® 2020 One Touch® Ping® Glucose management system Animas® Vibe™ Devices distributed before February 2012 and which do not contain the revised keypad are affected.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429