Hypoglycaemia risk with Accu-Chek Performa strips

6 July, 2007

Hypoglycaemia risk with Accu-Chek Performa diabetes testing strips

PHARMAC is working with Roche Diagnostics and Medsafe to address a potential health issue for people using the Accu-Chek Performa blood glucose strips.

People with diabetes use the testing strips to measure their blood glucose levels. PHARMAC has become aware that the Accu-Chek Performa strips may be providing higher blood glucose readings than they would with other strips and meters. As a result, these people may be at risk of giving themselves higher doses of insulin or other therapy and risking episodes of hypoglycaemia (low blood sugar).

The other blood glucose measuring strips and meters that are Government funded, Optium or Optium Xceed (supplied by Medica Pacifica) and Accu-Chek Advantage (supplied by Roche Diagnostics), are not affected by this issue.

PHARMAC and Roche Diagnostics have moved swiftly to address this potential problem, says Medical Director Dr Peter Moodie. Discussions have been held with Medsafe, Roche Diagnostics, and PHARMAC’s diabetes clinical advisory committee this week.

Dr Moodie says this is a potentially serious problem for people with diabetes, so PHARMAC has asked Roche Diagnostics to take a number of steps to remedy the situation.

These include asking Roche Diagnostics to stop distributing the Accu-Chek Performa system, and to take all steps to ensure that doctors and people with diabetes are aware of the calibration issue. This can help them make adjustments to their insulin regimen or other therapy (such as sulphonylureas) as necessary.

People using the Performa system have a number of actions available to them.

They can change back to their previous Roche Diagnostics meter (Accu-Chek Advantage) which remains fully funded by PHARMAC. Roche will exchange Performa test strips for Advantage test strips free of charge. People could make allowances for the difference in calibration to give themselves the correct insulin dose. Another type of funded blood glucose measuring system (Optium/Optium Xceed) is also available.

“Roche Diagnostics are taking responsible steps to address this issue that has come to light. We will continue to work with Roche Diagnostics, issue information that we feel is required and monitor the situation to ensure people’s health is not put at risk.”

ENDS

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