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MHRA orders investigation into diabetes kits after repeated faults

Practice The MHRA has called on all manufacturers of blood-glucose meters to provide risk assessments, after two manufacturers in a month reported software faults resulting in false readings if a patient’s glucose level was too high.

The MHRA has called on all manufacturers of blood-glucose meters to provide a risk assessment for their models, after two manufacturers in a month reported software faults resulting in false readings if a patient's glucose level was too high.


The MHRA issued a warning last month about two models of the Lifescan OneTouch Verio blood-glucose meter that switched off or gave false readings if the patient had a blood-glucose level of 56.8mmol/L or above. 


And, this week (May 1), the MHRA issued a warning about a similar fault in the FreeStyle InsuLinx – used by up to 40,000 people – prompting the watchdog to ask all manufacturers for a risk assessment and action plan for meters used to test blood-glucose levels of 56.8mmol/L.


The MHRA said it would act quickly to alert healthcare professionals and diabetes patients if there was evidence of a wider problem with blood-glucose meters

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Pharmacists should ask diabetes patients to check if they have the FreeStyle InsuLinx at home and contact the manufacturer, Abbott Diabetes Care, to receive a new meter or advice on how to update the software on their existing meter, the MHRA said.


The MHRA said it would quickly alert healthcare professionals and diabetes patients if there was evidence of a wider problem.


"People are unlikely to have very high blood-glucose levels. However, if they do, they need a fully working blood-glucose meter so they can get immediate medical attention," said MHRA director of medical devices John Wilkinson.


Diabetes UK director of health intelligence Simon O'Neill said pharmacists are in a good position to make patients with diabetes aware of the MHRA alert.


Patients can contact Abbot Diabetes Care on 0800 0885521 for a replacement FreeStyle InsuLinx meter or software update.


How can you help diabetes patients ensure they're getting the best treatment?

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