PRA number
2014/14141
Published date
Product description
The Accu-Chek Mobile blood glucose meter is used by people receiving insulin therapy to monitor their blood glucose levels.
Reasons the product is recalled
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 hazards to consumers
Potential for incorrect readings.
What consumers should do
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.
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.
Supplier
Roche Diagnostics Australia Pty Limited
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.