Events

Safety Alert Or Field Safety Notices for 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
    2019-02-19
  • Event Date Posted
    2019-02-19
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/accu-chek-insight-insulin-pumps-some-need-to-be-fitted-with-key-frames-to-reduce-the-risk-of-accidentally-unlocking-keys-or-pressing-the-bolus-buttons
  • 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
    The key lock function of the pump locks only the buttons on the front of the insulin pump.
    It does not lock the quick bolus keys on the top of the pump.The manufacturer has received reports of unintended boluses being delivered. Revised handling instructions were published in 2016 (MHRA issued MDA/2016/016) and now Roche Diabetes Care is providing users with key frames to fit onto all affected Accu-Check Insight pumps (i.e. pumps with serial numbers below 32100000) to further reduce the risk of accidental bolus delivery.
  • Reason
    Manufactured by roche diabetes care – important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (mda/2019/009).
  • Action
    Identify affected patients and pumps (serial numbers below 32100000) Ensure that all patients and carers: receive a copy of manufacturer’s Field Safety Notice (FSN) and instructions for use dated December 2018 understand the information detailed in the FSN apply the new key frames as instructed by the manufacturer Return the FSN acknowledgment form to Roche as currently they have not received enough responsesThis Medical Device Alert is to ensure that all relevant organisations are aware of this FSN and encourage their patients to apply the key frames.

Device

Accu-Chek® Insight insulin pumps

Manufacturer

Roche Diabetes Care
  • Manufacturer Address
    Roche Diabetes CareTel: 0800 731 2291burgesshill.insulinpumps@roche.comManufacturer FSCA Reference: SB_RDC_2015_05_2
  • Manufacturer Parent Company (2017)
    Roche Holding Ag
  • Source
    MHRA