Events

Alerte Ou Avis De Sécurité sur All Accu-Chek® Insight insulin pumps

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
    2017-09-20
  • Date de publication de l'événement
    2017-09-20
  • 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/all-accu-chek-insight-insulin-pumps-risk-of-alarm-failure
  • 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
    Due to an electrical issue there is a risk of a vibrator alarm failure and an intermittent audible alarm failure.The alarm failures will be detected during a pump’s self-test, which is prompted by changing the battery or insulin cartridge. If the failures are detected, the E7 error shows on the pump’s display.Users should contact the customer careline as instructed in the user manual if they cannot resolve an E7 error message.
  • Cause
    Manufactured by roche diabetes care – the audible and/or vibration alarms might not function, which may lead to hyperglycaemia if the user doesn’t see the notification message on the pump.
  • Action
    Identify all users of Accu-Chek Insight insulin pumps Ensure that all patients and carers: receive the manufacturer’s Field Safety Notice (FSN) understand the information detailed in the FSN and follow the advice given by the manufacturer check the display of the insulin pump regularly seek clinical advice if they are concerned and have an alternative insulin therapy available if necessary contact Roche Careline to get a replacement if the pump continues to display the ‘E7’ error message Return the FSN acknowledgment form to Roche as currently the manufacturer has not received sufficient responses

Device

All Accu-Chek® Insight insulin pumps

Manufacturer

Roche Diabetes Care
  • Adresse du fabricant
    Roche Diabetes CareTel: 0800 731 2291burgesshill.insulinpumps@roche.comManufacturer FSCA Reference: SB_RDC_2017_04
  • Société-mère du fabricant (2017)
    Roche Holding Ag
  • Source
    MHRA