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FDA Alerts Nationals for Correct Use of BGM

  • Data Source:Ministry of Health and Welfare
  • Created:2014-07-10
  • Last Updated:2017-01-11

In view of some domestic cases which showed incorrect blood sugar readings due to the improper operation of the blood glucose meter (BGM), the Food and Drug Administration (FDA) held a press conference in April to promote ‘the correct BGM usage to assure peace of mind in blood sugar control’, and issued two press releases on ‘user manual of BGM’ for public reference. Recently, the Australian health agency, Therapeutic Goods Administration (TGA), has also discovered incorrectly high blood sugar readings caused by improper BGM operation and subsequently issued warnings. The FDA once again urged the public to prevent incorrect BGM usage causing blood sugar reading errors, resulting in misjudgment of conditions or misuse of drugs that increases health risks. 

The FDA remarked that detection accuracy of domestic BGMs depends, apart from product quality, on the way people used them and their storage environment. Before using, one must read the product manual carefully and follow the manual instructions on how to operate and store the product. Also, the BGM must be sent back to the original factory regularly for calibration in order to assure its measurement accuracy. Please refer to the attachment for details of the proper usage and calibration of a BGM. In addition, the data recorded by domestic BGMs can only be used as a reference for tracking diseases; in case of inconsistency between the measurements and the symptoms, or of any doubts, the attending physician should be consulted for further treatment. 

The FDA has already established a safety monitoring mechanism on medical equipment on the market, actively issuing safety alerts on domestic and foreign medical equipment in order to protect the safe usage of medical devices of the public. In addition, the FDA reminded medical personnel and patients that in the discovery of poor quality medical devices or serious adverse reactions caused by the use of medical equipment, please report immediately to the National Reporting Center of Adverse Drug Reactions, Ministry of National Health and Welfare. Their reporting hotline is (02) 2396-0100, and their website is http: //