ACCU-CHEK Performa Strip 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Roche Diagnostics 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
    2011-06-21
  • 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 roche blood glucose strip the department of health (dh) today (june 21) draws public's attention to the recall of a medical device in france, accu-chek performa strip, a blood glucose test strip of roche diagnostics, as the strip may give falsely high blood sugar reading, thereby has the potential to cause fatal mis-management of diabetic patients. the alert comes to dh's notice through its surveillance system on medical device mishaps.  accu-chek performa strip is meant for used together with its home-use performa system by diabetic patients for self- monitoring of their blood glucose status. according to information available to the us food and drug administration, a specific lot (batch no.:470049) of the test strip referred to has the above deficiency. a spokesman for dh explains that falsely high blood glucose reading may cause a diabetic patient to mis-handle his condition, resulting in the life-threatening condition of hypoglycaemia. preliminary enquiry on the local supplier, roche diagnostics (hong kong) limited revealed that the affected lot of performa blood glucose strip is for sale in france only and has not been imported into hong kong. “though the affected lot has not been introduced into the hong kong market, the possibility of possession by individual diabetic patients cannot be ruled out, mindful of the option of internet trading and also the abundance of international travellers in hong kong. because of the dreaded consequences here, dh opts that a public alert is still warranted,”the spokesman stresses. "any one who has the failed lot of device in his possession must stop using it and contact roche diagnostic (hong kong) for follow-up," the spokesman urges. it is understood that the company has set up a hotline 2485 7512 to handle the matter. so far, the dh has not received any report of adverse events arising from use of the affected product.  however, the spokesman does remind that for those customers who have used the said product and are either feeling unwell or in doubt, they should consult their healthcare professionals for advice as soon as possible.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Safety alert over Roche blood glucose strip
  • Manufacturer

Manufacturer