Urgent Recall for Product Correction from Roche

ADEA has been advised by Roche of a recall for product correction letter to be sent to all Accu-Chek® Spirit Combo Insulin Pump and Accu-Chek® Spirit Insulin Pump users.

Please note: This is not a “product recall” but a “recall for product correction”. No product is being recalled, rather the guidance published should be followed where users experience the issue described.

Issue:

Roche became aware that some customers using the abovementioned Accu-Chek pump systems are experiencing an increase of mechanical errors with their insulin pump showing E6 and E10 error messages.
If users do not follow the cartridge change process step-by-step as described in the attached training leaflet, there is a potential risk of small insulin amounts dripping into the cartridge compartment.
Eventually, this may result in the insulin not being delivered as intended. However, such an issue is easily detectable as the pump will alert the user by acoustic, visual and vibration alerts.
Having evaluated the customer complaints and the products’ instructions for use, Roche have identified the opportunity to improve the handling instructions for the cartridge change to prevent the future occurrence of this issue.
Roche are certain that the improved handling information provided with this letter will support users in the reliable and satisfactory use of their Accu-Chek insulin pump.

Resolution:

As patient safety is their top priority, Roche Diabetes Care has initiated an enhancement of its handling instructions for the Accu-Chek Combo system (at link below – note instructions are valid for both abovementioned pump systems).
With these new and advanced handling instructions they aim to ensure that every user of the Accu-Chek Spirit Combo insulin pump can easily change the insulin cartridge without the risk of insulin dripping into the cartridge compartment.

The attached letter will go to all users of above mentioned systems either via email or letter today. For all user enquiries, please direct calls to the Accu-Chek Customer Care Pump Line: 1800 633 457

PwD AUS Letter Combo Piston Rod Blockage

Urgent Recall for Product Correction from Roche

ADEA has been advised by Roche of a recall for product correction letter to be sent to all Accu-Chek® Spirit Combo Insulin Pump and Accu-Chek® Spirit Insulin Pump users.

Issue:

Roche became aware that some customers using the abovementioned Accu-Chek pump systems are experiencing an increase of mechanical errors with their insulin pump showing E6 and E10 error messages.

If users do not follow the cartridge change process step-by-step as described in the attached training leaflet, there is a potential risk of small insulin amounts dripping into the cartridge compartment.

Eventually, this may result in the insulin not being delivered as intended. However, such an issue is easily detectable as the pump will alert the user by acoustic, visual and vibration alerts.

Having evaluated the customer complaints and the products’ instructions for use, Roche have identified the opportunity to improve the handling instructions for the cartridge change to prevent the future occurrence of this issue.

Roche are certain that the improved handling information provided with this letter will support users in the reliable and satisfactory use of their Accu-Chek insulin pump.

Resolution:

As patient safety is their top priority, Roche Diabetes Care has initiated an enhancement of its handling instructions for the Accu-Chek Combo system (at link below – note instructions are valid for both abovementioned pump systems).

With these new and advanced handling instructions they aim to ensure that every user of the Accu-Chek Spirit Combo insulin pump can easily change the insulin cartridge without the risk of insulin dripping into the cartridge compartment.