Events

Safety Alert for Clever Chek blood glucose monitoring system

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by TaiDoc Technology Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-05-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20120518.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Press release
  • Reason
    Medical device alert on a blood glucose monitoring system 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. ends.

Device

Clever Chek blood glucose monitoring system
  • Model / Serial
  • Product Description
    Press release: Medical device alert on a blood glucose monitoring system
  • Manufacturer
    TaiDoc Technology Corporation

Manufacturer

TaiDoc Technology Corporation