Accu-Chek Mobile blood glucose meter

Consumers and health professionals are advised that Roche Diagnostic Australia, in consultation with the TGA, is undertaking a recall for product correction of its Accu-Chek Mobile blood glucose meter due to the potential for incorrect blood glucose readings as a result of users not following the device instructions. To address this issue, Roche Diagnostic Australia is updating the instructions and training materials for Accu-Chek Mobile blood glucose meters.

The Accu-Chek Mobile blood glucose meter, pictured, is used by people receiving insulin therapy to monitor their blood glucose levels.

It has been identified that a small number of Accu-Chek Mobile blood glucose meters have given incorrect high blood glucose readings as a result of the user not following the device instructions. Improper handling can include using the meter with unclean hands, pressing the finger too hard and too long on the test field or smearing the blood while performing a test.

The updated instructions will be provided with new Accu-Chek Mobile kits, as well as be provided to health professionals to distribute to current users.

Information for consumers

If you have an Accu-Chek Mobile blood glucose meter, you can continue to use the device using the updated instructions.

Specifically:

• wash your hands with warm water and soap and rinse well, before drying them thoroughly with a clean towel
• always use a small, fresh and well-formed blood drop - do not test with a smeared or spread blood drop
• touch the test area gently and steadily, and apply the blood drop to the centre of the test area
• apply the blood drop to the test area immediately after obtaining the blood drop and remove your finger from the test area when the beep tone sounds and/or 'Test in progress' is displayed.

The updated instructions will be available from either your health professional or the Accu-Chek website.

If you are concerned about the accuracy of a blood glucose reading, you should refer to the possible sources of error listed in the user manual and perform a test with a control solution. After this, if you are still concerned about the reading, contact your health professional.

If you have any questions, you should call Roche on 1800 800 535 or speak to your diabetes nurse educator or other health professional.

Information for health professionals

If you are treating someone who uses an Accu-Chek Mobile blood glucose meter, inform them of this issue. Advise your patients of the importance of using the updated instructions to ensure that they get accurate test results.

If a patient is concerned about the accuracy of a blood glucose reading, advise them to refer to the possible sources of error listed in the user manual and perform a test with a control solution. After this, if they are still concerned about the reading, they should contact you.

Accu-Chek Mobile cassettes are only PBS-listed for patients on insulin therapy and should not be recommended to patients who would be unable to test gently and with a steady hand, as these are important requirements for using the device.

If you or your patients have any questions, call Roche on 1800 800 535.

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.