Events

Safety Alert Or Field Safety Notices for All Accu-Chek® Insight insulin pumps

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Roche Diabetes Care.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2017-09-20
  • Event Date Posted
    2017-09-20
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/all-accu-chek-insight-insulin-pumps-risk-of-alarm-failure
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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
  • Manufacturer Address
    Roche Diabetes CareTel: 0800 731 2291burgesshill.insulinpumps@roche.comManufacturer FSCA Reference: SB_RDC_2017_04
  • Manufacturer Parent Company (2017)
    Roche Holding Ag
  • Source
    MHRA