Accu-Chek Compact test strips and Accu-Chek Mobile tests 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Roche Diabetes Care 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2014-04-10
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Press release
  • 원인
    Safety alert over certain brands of roche diabetes care blood glucose test strips and blood glucose monitoring systems the department of health (dh) today (april 10) drew public attention to a safety alert issued by roche diagnostics (hong kong) limited concerning two glucose test strips namely accu-chek compact test strips and accu-chek mobile tests, respectively compatible with its home blood glucose monitoring systems accu-chek compactplus meter and accu-chek mobile meter, manufactured by roche diabetes care. according to the manufacturer, the test strips may lead to erroneously lowered blood glucose readings in patients undergoing ceftriaxone therapy, which is administered intravenously or intramuscularly. this limitation is not described in the product labelling. a spokesman for the dh said that ceftriaxone is a type of antibiotic used for treating a variety of infections such as respiratory infections or lower urinary tract infections. patients with diabetes who are receiving this specific therapy should stop using the affected blood glucose monitoring systems and contact their attending doctors. the spokesman explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycemia. "the dh's enquiry with the local supplier reveals that around 2 000 accu-chek compactplus meters and 200 accu-chek mobile meters have been sold locally," the spokesman said. so far, the dh has not received any local report of adverse events arising from use of the affected products. the company has set up a customer service hotline 2485 7512 or 2485 7508 to answer related enquiries. ends.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Safety alert over certain brands of Roche Diabetes Care blood glucose test strips and blood glucose monitoring system
  • Manufacturer

Manufacturer