Medical device alert on a blood glucose monitoring system

Hong Kong (HKSAR) - 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.

According to the MHRA, the product is distributed by BBI Healthcare Limited (BBI) and manufactured by TaiDoc Technology Corporation.While DH will continue to check with BBI and the manufacturer about any import of this product to Hong Kong, the spokesman said, "Any member of the public who has been using the product is advised to consult their healthcare professionals for advice on their need to switch to an alternative device with feedback and/or large display fonts."

The spokesman said DH had alerted the Hospital Authority, private hospitals, relevant institutions, and medical professional associations to this medical device alert.

So far, the department has not received any report of adverse events arising from this issue but shall monitor the development of the issue.

Published on: 2012-05-18

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