Events

Safety Alert Or Field Safety Notices for Accu-Chek® Insight Insulin pump system

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
    2016-09-01
  • Event Date Posted
    2016-09-01
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/accu-chek-insight-insulin-pump-system-risk-of-over-or-under-infusion-of-insulin
  • 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
  • Reason
    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
  • Manufacturer Address
    Roche Diabetes Care Accu-Chek Pump Care Line Telephone: 0800 731 22 91Email: burgesshill.insulinpumps@roche.comManufacturer FSCA Reference: SB_RDC_2015_05
  • Manufacturer Parent Company (2017)
    Roche Holding Ag
  • Source
    MHRA