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.
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