UK Warns of Underdosing With Roche’s Accu-Check Insulin Pump

The UK is warning of a risk of incorrect insulin dosage caused by leaking cartridges used with Roche’s Accu-Check Insight insulin pump system.

The Medicines and Healthcare products Regulatory Agency said that cartridges inserted incorrectly can leak insulin, resulting in under-delivery of insulin, which could lead to rapid deterioration of health, diabetic ketoacidosis or death.

Roche released an urgent Field Safety Notice detailing the problem and offered advice and additional training on the use of the device.

Leaking cartridges can be detected by regularly checking the pump a few hours following the cartridge change as the insulin would be visible through condensation in the pump’s cartridge compartment, the company said in the field alert.

Roche said it is updating its handling instructions immediately and will provide updated user manuals shortly at a later stage. In the meantime, users should:

1. Check the cartridge every time it is changed, including the rubber plunger at the bottom of the cartridge. Users should not use the cartridge if there is any damage or leakage seen or if the rubber plunger has been drawn above the white label band at the bottom of the cartridge.
2. Always hold the pump in an upright position when inserting the new cartridge.
3. Change the adapter tube every time the cartridge is changed.
4. Make sure the nose of the adapter is inserted into the notches of the pump’s housing at a right angle when placing a new adapter on the bayonet socket of the cartridge compartment. Otherwise the needle located in the nose of the adapter could bend and lead to leakage of insulin into the cartridge compartment.
5. Turn the adapter clockwise all the way until it stops. The adapter is correctly positioned when it is aligned with the pump’s housing.

Read the alert here: www.fdanews.com/08-18-16-Rocherecall.pdf. — Tamra Sami