Events

Insulin Reservoirs used with Paradigm Insulin Pump 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic Inc. 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
    2013-07-03
  • 사례 출판 날짜
    2013-07-03
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130703.html
  • 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
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: medtronic insulin reservoirs used with paradigm insulin pump medical device manufacturer, medtronic inc., has issued a medical device safety alert concerning the model mmt-326a and mmt-332a insulin reservoirs used with paradigm insulin pump. the affected lot numbers in hong kong are h8473271, h8492449 and h8627745. the manufacturer recalls these reservoirs due to the potential that reservoirs from these lots are at increased risk for leaking. a leak in the reservoir may result in delivery of less insulin than intended and, if there is an occlusion in the infusion set, the pump may not alarm. under-delivery of insulin can cause high blood sugar, which if untreated can lead to diabetic ketoacidosis. in most cases, the impact of a leaking reservoir is limited to a temporary increase in glucose levels. the manufacturer received a small number of reports of patients being hospitalized for diabetic ketoacidosis as a result of insulin under-delivery due to the reservoir leaking. the manufacturer has not been aware of any adverse incidents related to the above mentioned issues in hong kong. their investigation has indicated that this increased potential for reservoir leakage is related to abnormal wear of a manufacturing tool involved in the production of a component used in the affected lots of reservoirs. the manufacturer has implemented additional testing and inspection steps to ensure that currently produced reservoirs will not be subject to this problem. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 july 2013.

Device

Insulin Reservoirs used with Paradigm Insulin Pump
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Insulin Reservoirs used with Paradigm Insulin Pump
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH