Events

Alerte Ou Avis De Sécurité sur Accu-Chek® Insight Insulin pump system

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 Diabetes Care.

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
  • Date
    2016-09-01
  • Date de publication de l'événement
    2016-09-01
  • 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/accu-chek-insight-insulin-pump-system-risk-of-over-or-under-infusion-of-insulin
  • 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
    Manufactured by roche diabetes care - inadequately detailed handling instructions of the 'key lock' function of the pump may lead to unintentional operation, which could result in rapid and severe deterioration of health e.G. hypoglycaemia or diabetic ketoacidosis.
  • Action
    Identify users of the Accu-Chek Insight insulin pump system. Healthcare professionals should ensure that: patients/carers understand that the Quick Bolus keys on the top of the Accu-Chek Insight insulin pump are NOT locked by the Key Lock function patients/carers receive a copy of manufacturer’s Field Safety Notice (FSN), and are made aware of the enhanced handling instructions all new patients/carers have a copy of the FSN with their Accu-Chek Insight pump system. GPs should note that this is for their information only.

Device

Accu-Chek® Insight Insulin pump system

Manufacturer

Roche Diabetes Care
  • Adresse du fabricant
    Roche Diabetes Care Accu-Chek Pump Care Line Telephone: 0800 731 22 91Email: burgesshill.insulinpumps@roche.comManufacturer FSCA Reference: SB_RDC_2015_05
  • Société-mère du fabricant (2017)
    Roche Holding Ag
  • Source
    MHRA