Abbott Diabetes Care Issues Warning On Glucose Monitoring System

Field Safety Notice On FreeStyle Libre Flash Products

17.11.2014

Medical device manufacturer Abbott Diabetes Care has issued a field safety notice regarding potential problems related to its FreeStyle Libre Flash Glucose Monitoring System.

In the alert, the company has outlined that a software feature designed to disable the device’s sensor if it identifies a loss of power may not function correctly, which could lead to power loss not being properly highlighted.

The company has warned that in such circumstances, the sensor may provide previously collected glucose values as if they are the latest results, meaning erroneous information could be provided to the user. Abbott Diabetes Care has confirmed that erroneous results not recognised by the user may pose significant risk to their health.

The failure of some of these devices may lead to individuals suffering from either high or low blood sugar levels. The manufacturer has recommended any use of this product to seek advice from their doctor who experiences any of the following symptoms: Excessive thirst or urination, blurred vision, weakness, nausea, vomiting, abdominal pain, sweating, shakiness, extreme hunger, headache or experiencing a rapid heart rate.

Abbott Diabetes Care has advised that anyone who thinks they may have this issue should verify their blood glucose with test strips and also contact the company for further support.

A software update has been added to newly manufactured devices, while the company has stressed none of its other products are affected by the issue.

The MHRA has been notified regarding the problem.

Our specialist medical negligence solicitors will provide you with free initial advice on your compensation claim if you have suffered as the result of a defective or faulty medical products or medicines. View our Defective Medical Products Drugs Or Medicines Claims page for more information.


Expert Opinion
Considering how those with diabetes rely on glucose monitoring systems of this kind, it is very worrying to see such issues emerge in relation to this specific device.

"Monitoring blood glucose levels is vital in the treatment of individuals with diabetes and as such it is of paramount importance that medical equipment provided to monitor glucose levels is of the highest safety standard.

"While it is very welcome to see this field safety notice issued as a precautionary measure and a software update added to new devices, it is vital that Abbott Diabetes Care continues to work to understand how this problem emerged and what can be done to prevent it occurring on other products in the future.

"However, notwithstanding the issuance of a field safety notice, question marks remain over whether the individuals who use these personal medical devices are being informed of the issue. As recently as 26 September 2014 the MHRA issued a Medical Device Alert highlighting that delays in acting on field safety notices can compromise patient safety.

"This MDA also highlighted that the MHRA sometimes receives insufficient feedback, raising the question as to whether the majority of individuals concerned are in fact being notified or being left to use what may potentially be a dangerous device.

"The MHRA have the powers to enforce the regulation of medical devices more efficiently and with patient safety at the forefront. However, little evidence has been seen of this in recent years, save for the issuance of MDAs and FSNs.

"Individuals who are putting their faith in medical devices to work as intended expect a regulator which ensures that the devices placed on the market are fit for purpose, a regulator which will take action to ensure that similar adverse incidents will not happen again and, most importantly, to ensure that those individuals who may be harmed by a dangerous device are informed of what the problem is and how that problem can be safely rectified without harm occurring.

"Our work acting for those injured or affected by defective medical devices means we have seen on numerous occasions the huge problems such faults can cause. It is vital that lessons can be learned to ensure that only safe devices make it to market for use by consumers and patients and that the regulatory framework in place is utilised to protect the interests of individuals."
Kevin Timms, Solicitor