Regulator Asks those with Diabetes to Check Insulin Pumps

The Medicines and Healthcare products Regulatory Agency (MHRA) is asking people with a particular insulin pump to check the clock resets to the correct time and date when they change the battery or when the power is interrupted.



A fault with the Accu-Chek Spirit Combo insulin pumps, manufactured by Roche Diagnostics Ltd, means if the power is interrupted e.g. 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.

John Wilkinson, the MHRA’s Director of Medical Devices said:

“It is vital that people check their pumps 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.

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

“We continue to encourage people to report any issues involving medical devices to the MHRA via our Yellow Card Scheme.”

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. If they have any concerns about their level of insulin they should consult with their diabetes care team.”



Source: MHRA



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