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
  • Event Number
    MDA/2015/029
  • Date
    2015-08-04
  • Event Date Posted
    2015-08-04
  • 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-hyperglycaemia-from-rapid-pump-battery-depletion-or-unexpected-shut-down
  • 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
    Roche has identified that the use of low-quality batteries or users incorrectly confirming the battery type in the pump settings can lead to unexpected rapid power depletion or a shutdown of the pump. If this goes undetected, patients could experience hyperglycaemia due to under delivery of insulin.Roche has provided updated handling instructions and battery model recommendations in their FSN issued in June 2015 (manufacturer’s reference: SB_RDC_2015_04) but has not had enough replies to know that healthcare providers and users have received and acted on this advice.
  • Reason
    (roche diabetes care) advice from manufacturer to users about the correct battery specification and appropriate pump settings (mda/2015/029).
  • Action
    Identify users of all Accu-Chek® Insight insulin pumps Ensure that all users receive the manufacturer’s field safety notice (FSN), understand the problem, use batteries meeting the specification detailed in the FSN and confirm battery type in the pump settings Ensure systems are in place to supply users of Accu-Chek® Insight insulin pumps with batteries meeting the specification advised by Roche Ensure that all users are aware that if they experience a rapid decrease in power they should contact the Accu-Chek® Pump Care Line on 0800 731 22 91 Complete and return the FSN acknowledgement form to Roche

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