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1. their Accu Chek Mobile device safely and reliably by carefully following the instructions included in the new training leaflet 2 If patients have concerns about the accuracy of a bG reading they should refer to the possible sources of error listed in the user manual and perform a test with a control solution or they should contact their healthcare provider and follow the individual advice The Therapeutic Goods Administration has been notified of this action You will also be able to access this information online via www accu chek com au This action only applies to users of Accu Chek Mobile and does not apply to any other Accu Chek device We thank you for your understanding and for your cooperation in helping patients to get accurate readings from Accu Chek Mobile We apologize for any inconvenience this issue may cause you Should you have any additional questions or seek clarification please contact our Accu Chek Contact Centre on 1800 800 535 or your Roche Diagnostics representative Sincerely Roche Diabetes Care Australia Attachments Enhanced Instructions for use 2 22. URGENT RECALL FOR PRODUCT CORRECTION Accu Chek Mobile blood glucose meter enhanced instructions for use TGA Reference Number RC 2014 RN 00592 1 Dear Healthcare Professional We would like to inform you that we are introducing enhanced instructions and training for the use of the Accu Chek Mobile system The new and enhanced training materials will be included into the Accu Chek Mobile kits and will be available for you to distribute to current Accu Chek Mobile users The strip free Accu Chek Mobile blood glucose monitoring system requires particular awareness from people with diabetes regarding its proper handling due to the unique testing procedure Roche Diabetes Care has identified that a small number of people with diabetes using the Accu Chek Mobile device have experienced falsely elevated blood glucose readings when using the system as a result of not following the described and labelled handling instructions Such improper handling can include for example unclean hands contaminated with glucose containing substances pressing the finger too hard and too long on the test field or smearing the blood while performing a test Roche Diabetes Care has decided to enhance its training and handling instructions for the Accu Chek Mobile system increasing their visibility in the meter kit to ensure people with diabetes understanding of how to appropriately use the system This will enable the users to obtain safe and reliable blood
3. glucose bG readings at all times Attached you will find new training leaflet that is provided in the package for the Accu Chek Mobile kits This will be accompanied by additional training measures for people with diabetes online and offline Actions required from you 1 Ensure that your patients are aware of the new training materials included within the packaging 2 Ensure that your patients understand how they should use Accu Chek Mobile properly to get accurate results according to the specified instructions e Wash your hands with warm water and soap Dry your hands thoroughly before obtaining a blood sample e Forma proper blood drop and apply it to the centre of the test field e Immediately apply the blood gently to the test field after you have created the blood drop e Do not press against the test field on the tape e Touch the test area gently and remove your finger immediately after having applied the blood e Your finger should be removed from the test field when the beep tone sounds and or test in progress is displayed 3 Please remember the Accu Chek Mobile cassettes are PBS listed for patients on insulin therapy 1 2 only Do not recommend the Accu Chek Mobile system to patients who are obviously not able to follow the specified instructions as being able to test gently and with a steady hand is an important requirement of Accu Chek Mobile Actions required from your patients 1 Patients can continue to use
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