TRUEresult blood glucose test strips

Recall - risk of undetected high blood sugar levels due to incorrect readings

20 May 2016

Consumers and health professionals are advised that Nipro Australia, in consultation with the TGA, are recalling one batch of TRUEresult blood glucose test strips (10 pack) due to a risk of giving incorrect readings. The affected batch number is KS1741, with expiry date 25/06/2018.

Trueresult test strips and blood glucose monitoring system packaging

TRUEresult blood glucose test strips are used with the TRUEresult blood glucose monitoring system by people with diabetes to measure blood sugar levels.

It has been identified that some of the test strips from the affected batch may have been contained within an open test strip vial. Being exposed to the outside environment can affect test strip performance and lead to false low readings.

If this occurs, the patient could experience undetected hyperglycaemia (high blood sugar), which may lead to improper treatment. Treatment based on false low readings can raise blood sugar levels further and lead to hyperglycaemia (high blood sugar) that may require medical intervention.

No other batches or pack sizes of TRUEresult blood glucose test strips are affected by this recall.

Information for consumers

If you or someone you care for uses TRUEresult blood glucose test strips, please be aware of this issue.

Check any unused test strips to see if they are from batch number KS1741, with expiry date 25/06/2018. The batch number is displayed at the bottom of the left side of the package.

If you have test strips from the affected batch, do not use them. Test your blood sugar level with test strips from an unaffected batch or use an alternative device.

If you have any questions or concerns about this issue, speak to your diabetes nurse educator or other health professional.

Information for health professionals

Nipro Australia has written to health professionals to provide further information about this issue, including details of the recall procedures.

If you are treating someone who uses TRUEresult blood glucose test strips, please advise them of this issue, including checking any unused test strips to ensure they are not from batch number KS1741, with expiry date 25/06/2018.

Check all unused stock of TRUEresult blood glucose test strips. The batch number is displayed at the bottom of the left side of the package.

If you find any test strips from the affected batch, quarantine those products and contact Nipro Australia on 1800 451 737 to arrange their return.

If you have any questions or concerns about this issue, contact Nipro Australia on 1800 451 737.

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.