Events

Safety Alert Or Field Safety Notices for Insulin infusion pump

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 Diagnostics Ltd.

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
  • Event Number
    MDA/2014/008
  • Date
    2014-03-10
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-insulin-infusion-pump-risk-of-delay-in-treatment
  • 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
    Risk of delay to treatment.There is an increased risk that the vibration alarm will not work, as a result of a changed component.  This fault will only be detected at pump start up, when it will display an ‘E-7’ error message and give an audible signal, but will fail to start.Roche will replace pumps that display this ‘E-7’ error message, but does not intend to replace all potentially affected pumps.
  • Reason
    (roche diagnostics ltd) increased risk that the vibration alarm will not work as a result of a changed component. (mda/2014/008).
  • Action
    Identify affected pumps. If a delay to insulin therapy could compromise patient safety, consider using an alternative device. When using these pumps: ensure that users are aware of the problem ensure that users have a syringe or insulin pen available in case the pump stops if the pump displays an ‘E-7’ error, contact Roche for a replacement Report any adverse incidents involving these devices to the MHRA.

Device

Insulin infusion pump
  • Model / Serial
  • Product Description
    Insulin infusion pump: Accu-Chek Spirit Combo insulin pump Manufactured by Roche Diagnostics Ltd.All pumps with serial numbers in the range 10171897 to 10281629 (inclusive).
  • Manufacturer
    Roche Diagnostics Ltd

Manufacturer

Roche Diagnostics Ltd
  • Manufacturer Address
    Accu-Chek Pump Careline Tel: 0800 731 2291
  • Manufacturer Parent Company (2017)
    Roche Holding Ag
  • Source
    MHRA