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MHRA issues medical device alert about insulin pump

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The Medicines and Healthcare products Regulatory Agency has issued a medical device alert regarding a fault on a particular type of insulin pump.

The fault has been found with the Accu-Chek Spirit Combo insulin pumps, manufactured by Roche Diagnostics, according to the alert from the MHRA.

It means if the power is interrupted – for example, during a battery change – the pump will reset to the default date and time. If this change goes unnoticed, it may affect the time of insulin delivery.

The MHRA is asking patients and clinicians to check the device to make sure its clock resets to the correct time and date when the battery is changed or when the power is interrupted.


Accu-Chek insulin pump

John Wilkinson, the MHRA’s director of medical devices said it was “vital” that the pumps were checked after an interruption in power supply.

“People should not stop using these pumps, or switch to an alternative device, without first discussing it with a healthcare professional,” he said.

“If the pump is affected by this fault, people should seek a replacement at the earliest opportunity by contacting Roche 0800 701 000,” he added.

Simon O’Neill, director of health intelligence at Diabetes UK, said: “Ensuring the correct level on insulin is vitally important in the management of diabetes.

“People using these pumps should contact the manufacturer for a replacement if they experience any problems,” he said. “If they have any concerns about their level of insulin they should consult with their diabetes care team.”

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