Regulatory Focus™ > News Articles > UK’s MHRA Cautions Diabetics on Roche’s Leaky Insulin Cartridges

UK’s MHRA Cautions Diabetics on Roche’s Leaky Insulin Cartridges

Posted 16 August 2016 | By Zachary Brennan 

UK’s MHRA Cautions Diabetics on Roche’s Leaky Insulin Cartridges

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that patients with diabetes using Roche’s Accu-Chek Insight insulin pump should be careful when inserting pre-filled insulin cartridges as Roche has reported an increasing number of instances when patients experienced leaking insulin cartridges.

“Users of Accu-Chek Insight insulin pump system with NovoRapid PumpCart cartridges, can check for any leaked insulin in the cartridge compartment by regularly checking the pump a few hours after changing the cartridge as any leaked insulin would be visible,” MHRA said.

The regulator also released a device alert on Monday, cautioning, “Cartridges inserted incorrectly can leak insulin into the cartridge compartment, resulting in an under-delivery of insulin, which may lead to rapid deterioration of health, diabetic ketoacidosis or death.”

Though Roche did not indicate in its “urgent field safety notice” how many patients are dealing with the leaking cartridges, the company noted: “We have seen an increase in customer feedback from people with diabetes using the Accu-Chek Insight insulin pump system and experiencing leaking insulin cartridges. We have immediately investigated this feedback and identified the need to update the handling instructions and user manual” of the pump for inserting or changing the pre-filled insulin cartridges.

John Wilkinson, MHRA’s Director of Medical Devices, added in a statement: “It’s important that cartridges are correctly inserted into these pumps to ensure you receive the correct level of insulin. You should take care when changing cartridges to make sure they do not leak, reducing the amount of insulin being delivered. We continue to encourage people to report any issues involving medical devices to MHRA via our Yellow Card Scheme.”

MHRA has set a deadline for action of 26 September 2016.

History of Issues

This is not MHRA's first warning to consumers or health professionals about the device. Last August, MHRA said users are receiving false high glucose readings from their Accu-Chek devices.

And Roche and MHRA have alerted users of Accu-Chek devices about multiple issues during 2015, from the risk of incorrect results when taking the antibiotic ceftriaxone to the need to follow testing procedures to avoid falsely high readings. MHRA warned patients of the need to follow instructions in June 2014, but it seems the message is yet to reach every user, with the regulator noting that it continues to receive reports of falsely high blood glucose readings.

The regulator also called on healthcare professionals to ensure patients who use the device understand the testing workflow and know what to do in the event of a reading outside their normal range. False glucose readings can occur when patients fail to clean and dry their hands before testing, or when the blood droplet is applied incorrectly.


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