Events

continuous glucose monitoring system DexCom PLATINUM G4 and DexCom G5 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Dexcom, 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
  • 사례 ID
    I1603-87
  • 사례 연번
    2013DM-0010746
  • 날짜
    2016-03-02
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=154
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer reports that he was notified of some cases in which the referenced medical devices do not receive an existing warning or sound alarm, therefore, severe hypoglycemia (low blood sugar level) or severe hyperglycemia (high blood sugar levels) may not be detected. blood), leading to the potential occurrence of adverse events on patients.

Device

continuous glucose monitoring system DexCom PLATINUM G4 and DexCom G5
  • 모델명 / 제조번호(시리얼번호)
    MT20649-1, MT20649-2, MT22719- 1 and MT22719-2
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 제품 설명
    It is a glucose monitoring device designed to identify trends and monitor patterns in people of two or more years with diabetes. It is designed to be used by patients in their own home and in health centers. It is an additional device that complements, but replaces, the information obtained from standard glucose monitoring devices to be used at home. It helps to detect episodes of hyperglycemia and hypoglycaemia, allowing to adjust the treatments of acute and chronic cases.
  • Manufacturer
    Dexcom, Inc

Manufacturer

Dexcom, Inc