Events

QUICK-SET PLUS Infusion Set 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Medtronic Diabetes 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
  • 사례 ID
    774
  • 날짜
    2004-06-14
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    For the Brazilian users of insulin pump and its disposables, this communication is purely informative since the product involved in this process, Quick-set Plus is not commercialized in Brazil, nor compatible with MMT-506 pumps, MMT-507 and MMT-508 used in the country.
  • 원인
    Interruption of insulin flow in patients using this infusion set. this problem resulted in relevant complications, including hospitalizations.
  • 조치
    Medtronic Comercial Ltda. communicates to its clients and healthcare professionals that it is conducting a recall process for the Quick-setÒ Plus infusion set in the United States because of problems that may interrupt the flow of insulin in patients using this infusion set. This problem has resulted in relevant complications, including hospitalizations. Medtronic is asking patients outside of Brazil to contact their customer service center by phone (800) MINIMED (1-800-646-4633) - USA, to exchange any Quick-set Plus infusion set not used by other infusion set models currently marketed by Medtronic. In the event that continued use of the Quick-set Plus infusion set is required while replacement infusion sets are in transit, Medtronic recommends that patients monitor their blood glucose frequently and are prepared to treat any elevated glucose levels that may occur through injections. Patients are also being instructed to contact their health care providers if there are excessive increases or decreases in glucose levels or any other question relevant to their treatment. Information on changing the Quick-set Plus infusion set is available at www.minimed.com/QSP. This recall applies to all Paradigm Quick-Set Plus infusion set models (models: MMT-359S6, MMT -359S9, MMT-359L6 and MMT-359L9). This action only affects Quick-set Plus infusion sets; no other equipment or infusion set manufactured by Medtronic are involved in this recall.

Device

QUICK-SET PLUS Infusion Set

Manufacturer

Medtronic Diabetes
  • Source
    ANVSANVISA