Events

Field Safety Notices about Accu-Chek Spirit Combo insulin pump (Pumps with serial numbers in the range 10171897 to 10281629 inclusive)

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland 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
    Field Safety Notice
  • Event Number
    SN2014(13)
  • Date
    2014-03-24
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/accu-chek-spirit-combo-insulin-pump-(pumps-with-serial-numbers-in-the-range-10171897-to-10281629-inclusive)&id=52cdf925-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    There is an increased risk that, due to a component change, vibration alarm defects may cause an ‘e-7’ alert message. this fault will 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. the other pump alarms – visual and audible - are not affected by this issue. pumps with serial numbers in the range 10171897 to 10281629 (inclusive) are potentially affected. these pumps were distributed to the irish market between late 2010 and early 2012 and to date, no ‘e-7’ issues related to vibration alarm defects have been reported from ireland.
  • Action
    1. Identify affected pumps.  2. If a delay to insulin therapy could compromise patient safety, consider using an alternative device.  3. 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 device  4. Ensure that appropriate personnel are made aware of this notice. Please also pass this notice on to any end user or organisation where the potentially affected insulin pumps have been transferred

Device

Accu-Chek Spirit Combo insulin pump (Pumps with serial numbers in the range 10171897 to 10281629 ...
  • Model / Serial
  • Product Description
    Accu-Chek Spirit Combo insulin pump (Pumps with serial numbers in the range 10171897 to 10281629 inclusive)
  • Manufacturer
    Roche Diagnostics Ltd.

Manufacturer

Roche Diagnostics Ltd.