Events

Alerte Ou Avis De Sécurité sur Insulin infusion pump

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 Roche Diagnostics Ltd.

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
  • Numéro de l'événement
    MDA/2014/008
  • Date
    2014-03-10
  • Date de publication de l'événement
    2014-12-17
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/medical-device-alert-insulin-infusion-pump-risk-of-delay-in-treatment
  • 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
    Risk of delay to treatment.There is an increased risk that the vibration alarm will not work, as a result of a changed component.  This fault will only be detected at pump start up, when it will display an ‘E-7’ error message and give an audible signal, but will fail to start.Roche will replace pumps that display this ‘E-7’ error message, but does not intend to replace all potentially affected pumps.
  • Cause
    (roche diagnostics ltd) increased risk that the vibration alarm will not work as a result of a changed component. (mda/2014/008).
  • Action
    Identify affected pumps. If a delay to insulin therapy could compromise patient safety, consider using an alternative device. When using these pumps: ensure that users are aware of the problem ensure that users have a syringe or insulin pen available in case the pump stops if the pump displays an ‘E-7’ error, contact Roche for a replacement Report any adverse incidents involving these devices to the MHRA.

Device

Insulin infusion pump
  • Modèle / numéro de série
  • Description du dispositif
    Insulin infusion pump: Accu-Chek Spirit Combo insulin pump Manufactured by Roche Diagnostics Ltd.All pumps with serial numbers in the range 10171897 to 10281629 (inclusive).
  • Manufacturer
    Roche Diagnostics Ltd

Manufacturer

Roche Diagnostics Ltd
  • Adresse du fabricant
    Accu-Chek Pump Careline Tel: 0800 731 2291
  • Société-mère du fabricant (2017)
    Roche Holding Ag
  • Source
    MHRA