Medical Device Alert on TaiDoc's Blood Glucose Monitoring System

5/18/2012 8:36:35 AM

The Department of Health (DH) today (May 18) drew public attention to a medical device alert on the Clever Chek blood glucose monitoring system, which is a home-use blood glucose monitoring system for visually impaired patients. The DH, through its routine surveillance on medical devices, noticed the above alert issued by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA). The Agency warned that the Clever Chek meter does not have a blood glucose test strip under-fill detection mechanism, nor does it provide feedback to users when sufficient blood has been applied. There is a potential for the meter to produce falsely low blood glucose results if the test strips are under-filled, and falsely high results if over-filled, leading to inappropriate insulin administration.

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