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1. HCP Letter Accu Chek Insight battery Urgent field safety notice SB_RDC_2015 04 lt Enter address here gt Location Date Important information on the Accu Chek Insight insulin pump system Update of the handling instructions to ensure usage of the appropriate batteries and optimal battery lifetime Dear Healthcare Professional We recently received feedback from a limited number of people with diabetes using the Accu Chek Insight insulin pump system that they are experiencing rapid power depletion or a system shut down due to battery issues We have thoroughly investigated these cases and identified low quality batteries or an incorrectly selected battery type on the pump to be the root cause of such battery issues Using the high quality batteries described below and selecting the correct battery type will prevent the future occurrence of this issue We sincerely apologize for any inconvenience this may have caused you and your patients and hope the enhanced handling information provided below supports your patients in the safe reliable and satisfactory use of the Accu Chek Insight insulin pump system Recommended actions to be taken 1 Based on our investigation results we recommend the following high quality batteries for use with the Accu Chek Insight insulin pump Lithium battery Use only lithium batteries that comply with IEC 60086 4 e g Energizer Ultimate Lithium FRO3 1 5V AAA FRO3 These have been succes2. and return to Roche using your preferred method 2 Ensure that patients using the Accu Chek Insight insulin pump system where is has been supplied directly by yourself and or your facility receive a copy of the FSN documentation Thank you in advance for your understanding and co operation If you have any further questions please do not hesitate to contact our Accu Chek Customer Care line on 0800 731 22 91 or yourlocal Accu Chek sales representative at any time Kind regards Roche Diabetes Care 2 2
3. ry of insulin Using the recommended batteries will enable early detection of low power and remind the user to change the battery Selecting the incorrect battery type on the insulin pump may impact the detection of the remaining voltage in the battery which can also lead to the above described issues as lithium and alkaline batteries have different lifetime characteristics To avoid this risk it is key to follow the battery recommendation and change the battery as described in the user manual of the Accu Chek Insight insulin pump As patient safety is our top priority Roche Diabetes Care has started to further enhance its handling instructions for the Accu Chek Insight insulin pump With this we aim to ensure that every user of the Accu Chek Insight insulin pump selects the appropriate batteries for the system This would lessen the risk of a sudden decrease in voltage or an unexpected shut down of the insulin pump If your patients experience a rapid decrease in power please advise them to contact our Accu Chek Customer Care line on 0800 731 22 91 This issue only affects the Accu Chek Insight insulin pump system and the competent authority as well as users of the Accu Chek Insight insulin pump system who have received the product directly from Roche have been informed about this field action Please forward this information to all those who need to be aware within your organisation Actions 1 Please complete the enclosed Acknowledgement form
4. sfully tested with the Accu Chek Insight insulin pump Please note Roche Diabetes Care UK only provide Lithium batteries as part of service packs and battery orders Alkaline battery Use only high quality alkaline batteries 1 5V AAA LRO03 that are suitable for ke a energy intensive devices such as those requiring a flash This is shown by a Ay _ Flash symbol on the packaging see picture Please advise your patients not to use carbon zinc or rechargeable nickel cadmium NiCd NiMH batteries with the Accu Chek Insight insulin pump Roche Diabetes Care Insulin Delivery Systems Pump Care Line Tel 0800 731 2291 2 Please also train your patients to make sure to always confirm antery the correct battery type on the insulin pump upon the battery change ii see image D Alkaline Battery type If users follow the battery recommendation and handling instruction provided above the pump will work safely and reliable for up to 30 days with a new high quality lithium battery if used as directed What are the risks of using low quality batteries and or selecting the incorrect battery type Using low quality batteries may lead to a very short battery lifetime of only a few days and sudden power depletion which may cause an unexpected shut down of the insulin pump In some cases the pump may not even alarm due to a very rapid decrease in voltage An unexpected shut down of the insulin pump could potentially result in under delive
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