Consumers and health professionals are advised that Roche Diagnostic Australia, in consultation with the TGA, has initiated a recall for product correction for all models of its Accu-Chek Spirit Combo and Accu-Chek Spirit insulin pumps.
Accu-Chek Spirit Combo and Accu-Chek Spirit insulin pumps deliver continuous doses of insulin to help patients with diabetes maintain safe blood glucose levels.
It has been identified that some pump users are experiencing mechanical errors. Investigation has revealed that this may be due to small amounts of insulin dripping into the cartridge compartment during the cartridge change process.
Over time, this can result in damage to the pump's piston rod and lead to insulin not being delivered as intended.
If this occurs, the pump will give acoustic, vibration and visual alerts (E6 and E10 error messages).
To address this issue, Roche Diagnostic Australia is providing advanced step-by-step instructions for the cartridge change process to Accu-Chek Spirit Combo and Accu-Chek Spirit insulin pump users.
Specifically, users are instructed to assemble the cartridge, adapter and infusion set tubing before inserting the new cartridge into the insulin pump.
Information for consumers
Roche Diagnostic Australia is contacting Accu-Chek Spirit Combo and Accu-Chek Spirit insulin pump users to inform them of this issue and to provide updated instructions for the cartridge change process.
It is important that users follow this process step-by-step to avoid the identified risks.
If you or someone you care for uses an Accu-Chek Spirit Combo or Accu-Chek Spirit insulin pump and you experience an E6 or E10 error message, or if you have not received the updated instructions, contact Accu-Chek Customer Care on 1800 633 457.
If you continue to have any questions or concerns about this issue, you can phone Accu-Chek Customer Care on the above number or speak to your diabetes nurse educator or other health professional.
Information for health professionals
Roche Diagnostic Australia is contacting Accu-Chek Spirit Combo and Accu-Chek Spirit insulin pump users to inform them of this issue and to provide updated instructions for the cartridge change process.
If you are treating a patient who uses an Accu-Chek Spirit Combo or Accu-Chek Spirit insulin pump, ensure that they are aware of this issue.
If they experience an E6 or E10 error message or have not received the updated instructions from Roche Diagnostic Australia, advise them to contact Accu-Chek Customer Care on 1800 633 457.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.