Device Alert Issued On Roche Diagnostics’ Accu-Chek Spirit Combo

Concerns Regarding Risks If Insulin Pump’s Power Is Interrupted

21.01.2015

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert regarding the Accu-Chek Spirit Combo insulin pump, following concerns related to patient safety.

According to the notice, which relates to all of the devices, there is a risk of users suffering hyperglycaemia or hypoglycaemia if the pump’s power is interrupted.

The alert that such an interruption could reset the default date and time on the pump, leaving to  a shift in the basal rate time block, which in turn could affect insulin delivery. According to the MHRA, patients with impaired vision could be at particular risk of the issue.

The MHRA has urged any users to identify affected pumps and have a syringe or insulin pen available as a back-up.

In addition, it calls on them to contact Roche for a replacement pump if the problem arises.

Expert Opinion
The issues identified with the Accu-Chek Spirit Combo are clearly a concern and it is vital that anyone who uses the pump, as well as medical professionals, are made fully aware of the problem.

"As the medical device alert explains, the issue raised could have a significant impact on the welfare and safety of those who rely on this type of pump and the seriousness of the potential consequences cannot be underestimated. Whilst the recall notice advises that individuals carry a syringe or insulin pen as back-up, we recommend that those with insulin pens ensure that their back-up is not a recently recalled insulin pen manufactured by Owen Mumford.

"Sadly this is just the latest in a series of concerns to be raised regarding medical devices, in particularly insulin pens and pumps. Those who use such products should be able to do so safe in the knowledge that they pose no risk to their health.

"This is why it is absolutely vital that steps are taken to determine how this issue emerged and why it was not identified or tackled prior to the device reaching market. We also call upon the MHRA to carry out an investigation to establish the reason why a number of insulin administration devices have been failing.

"We have seen numerous cases when people have suffered serious illness and injury as a result of products which are subsequently found to have faults.

"Everything possible should be done to learn lessons which ensure safety improves."
Kevin Timms, Solicitor