Important Safety Alerts

The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a medical device alert concerning Accu-Chek Spirit Combo insulin pump, manufactured by Roche Diagnostics. The affected serial numbers are from 10171897 to 10281629 (inclusive).

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. There is a risk of treatment delay.

The manufacturer advises users that:

• If a delay to insulin therapy could compromise patient safety, they should consider using an alternative device.
• When using these pumps, they should have a syringe or insulin pen available in case the pump stops.
• If the pump displays an 'E-7' error, they should contact local supplier for a replacement.

For details, please refer to MHRA website
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON392813

If you are in possession of the product, please contact your supplier for necessary actions.

Posted on 12 Mar 2014