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Saudi Food and Drug Authority is publishing an announcement about Blood Glucose Meters Model CLEVER CHEK TD-4232

Saudi Food and Drug Authority is publishing an announcement about Blood Glucose Meters Model CLEVER CHEK TD-4232

icon التاريخ: 2012-06-25
نوع المواضيع: General Health

<div>​Saudi Food and Drug Authority would like to warn healthcare practitioners, and all patients about Blood Glucose Meters Model CLEVER CHEK TD-4232 Manufactured by TaiDoc Technology – in Taiwan , may not alarm if insufficient blood is applied .
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<div>This meter doesn’t have a blood glucose test strip under-fill detection mechanism, nor does it provide feedback to the users when sufficient blood has been applied. This meter does not alert users when insufficient blood has been applied.</div>

<div>Potential for falsely low blood glucose results if the test strips are under-filled, and falsely high results if over-filled. This could result in inappropriate insulin administration.</div>

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<div>SFDA assure that CLEVER CHEK blood glucose meter hasn’t obtain market authorization from SFDA and hasn’t been cleared via KSA ports of entry.</div>

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<div>Saudi Food and Drug Authority recommend to use alternative blood glucose monitoring devices, possibly with feedback and/or large display fonts.</div>

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<div><font >Saudi Food and Drug Authority encourages all healthcare practitioners and all patients to Report any adverse event associated with medical devices through the National Center for Medical Devices Reporting : <a href="http://ncmdr.sfda.gov.sa/"><u><font >http://ncmdr.sfda.gov.sa</font></u></a&gt; </font></div>
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رخصة مركز متابعة دراسات سريرية