Risk of alarm failure in Accu-Chek Insight insulin pumps could lead to hyperglycaemia

Another issue with insulin devices. These life-saving devices are so important in modern society, so any issue with them is huge.

Diabetics and healthcare providers are urged to check Accu-Chek Insight insulin pump display screens regularly as the alarms on the devices may reportedly fail due to an electrical error. Manufactured by Roche Diabetes Care, the audible alarm and the vibration alarm may not work properly, therefore failing to notify the user of high blood-sugar levels.

A very serious issue indeed.

About the device

The Accu-Check Insight device, similar in size and look to a pager, is attached to the user through a tube to measure and deliver doses of insulin when the user’s blood-sugar levels are too high. Some diabetes sufferers struggle produce enough insulin naturally to control their blood-sugar levels, so without an external insulin dose, they could suffer from high blood-sugar; also known as hyperglycaemia.

In serious cases of hyperglycaemia, diabetics could go into a coma or suffer severe dehydration.

Users at risk

Advertised as a device that lets users get on with their lives, many users of the device may rely on audible or vibration alert, rather than manually check the display for high or low blood-sugar levels. This means if the audible and/or the vibration alert fails, the user may not realise there is a problem.

Roche’s Field Safety Notice provides the example of users who rely on the audible or vibrating alarm when sleeping to let them know their blood-sugar level is too high, putting people at risk of hyperglycaemia.

Spotting the problem

If there is a problem with the alarms, it should reportedly be detected by the device when the battery or insulin cartridge is changed. When detected, an ‘E7’ message should show up on the device display screen. If the user is unable to resolve the E7 error message by using the instructions manual, the user ought to contact Roche by calling the customer helpline. If unresolved, the user may have to ask for a replacement device.

For a medical device that is designed to give the user freedom from having to spend a lot time to check their blood-sugar levels and inject insulin manually when needed, the error is sure to put a lot of people under a lot of stress to check if the device is not working.  The defect arguably does anything but “inspire confidence in diabetes management,” as labelled on the device website.

Related product defects

Only last year, the Medicines and Healthcare products Regulatory Agency issued a press release warning users of the same products to check if they are using the devices correctly as they could easily overdose on insulin and risk hypoglycaemia (low blood sugar). The issue prompted Roche to improve their instructions on how to use the devices.

For those who are concerned about the devices, users are encouraged to speak to a GP or other medical professional about the issue.