Events

Autopen 24 1 unit pen, Autopen 24 2 unit pen, Autopen Classic 1 unit pen, Autopen Classic 2 unit pen 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 manufacturer #17429 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2014/047
  • 사례 연번
    CON491138
  • 날짜
    2014-12-17
  • 사례 출판 날짜
    2014-12-17
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON491138?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Risk of hyperglycaemia, which could lead to immediate and long-term deterioration of health. affected devices may have a mechanical fault which could cause the dose selector to revert to zero resulting in the devices not delivering the correct dose of insulin.
  • 조치
    Advise users to stop using affected devices and to seek a replacement pen.  Ensure that a suitable alternative device is available to enable them to maintain their insulin regime. Discontinue supply of all affected devices. Quarantine and return any remaining stock of affected devices to the manufacturer. Pharmacists Healthcare professionals Those involved in purchasing, supplying and using these devices.

Device

Autopen 24 1 unit pen, Autopen 24 2 unit pen, Autopen Classic 1 unit pen, Autopen Classic 2 unit pen
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Autopen 24 1 unit pen Product code: AN4210. PIP code 293-5096. Autopen 24 2 unit pen. Product code: AN4200. PIP code 293-5070. Autopen Classic 1 unit pen. Product code: AN3810. PIP code 273-3178. Autopen Classic 2 unit pen. Product code: AN3800. PIP code 260-3561. To identify affected devices still within their packaging, look for the following packaging lot codes on the outer carton. Packaging lot code Product code Product name 7VJ AN3810 3ml 1 Unit Autopen Classic 7WB AN4200 Autopen 24 3ml 2 Unit 7WC AN4210 Autopen 24 3ml 1 Unit 7WD AN3800 3ml 2 Unit Autopen Classic 8CN AN4200 Autopen 24 3ml 2 Unit 8CP AN4200 Autopen 24 3ml 2 Unit 8CR AN4210 Autopen 24 3ml 1 Unit 8EL AN3800 3ml 2 Unit Autopen Classic 8EM AN3810 3ml 1 Unit Autopen Classic 8JK AN4210 Autopen 24 3ml 1 Unit 8JM AN3800 3ml 2 Unit Autopen Classic 8JN AN3810 3ml 1 Unit Autopen Classic 8JP AN4210 Autopen 24 3ml 1 Unit 8VV AN4200 Autopen 24 3ml 2 Unit 8VW AN4200 Autopen 24 3ml 1 Unit To identify affected devices without packaging look for the following production lot codes, which can be found on the lower part of the pen body. Production lot code (stamped on pen) Product code Product name 7RT AN3810 3ml 1 Unit Autopen Classic 7PN AN4200 Autopen 24 3ml 2 Unit 7PP AN4210 Autopen 24 3ml 1 Unit 7RV AN3800 3ml 2 Unit Autopen Classic 8KK AN3800 3ml 2 Unit Autopen Classic 8XD AN4200 Autopen 24 3ml 2 Unit
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429