Events

Insulin pens 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Novo Nordisk 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 연번
    MDA/2017/024
  • 날짜
    2017-08-24
  • 사례 출판 날짜
    2017-08-24
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/insulin-pens-novopen-echo-and-novopen-5-certain-batches-risk-of-hyperglycaemia-due-to-cartridge-holder-weakening-when-exposed-to-certain-household-chemicals
  • 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
    In July 2014, a redesigned cartridge holder for NovoPen Echo and NovoPen 5 was implemented to improve robustness. However, the redesigned cartridge holder can become weakened if it is exposed to chemicals in cleaning agents, sunscreen and food grease, and the snaps keeping the cartridge holder in place may crack or break off.There are 3 types of fault that can occur:‘Snap cracked’
    ‘One snap broken off’
    ‘Both snaps broken off’In April 2016 Novo Nordisk decided to change production back to the original cartridge holder so that in future all products would be produced with the original cartridge holder. This was effective from 1 September 2016.Novo Nordisk issued an FSN in July 2017 to recall affected cartridge holders.
  • 원인
    Manufactured by novo nordisk - recall and replacement of specific batches of cartridge holder (mda/2017/024).
  • 조치
    Identify patients who use NovoPen Echo and NovoPen 5 insulin pens and inform them of the manufacturer’s Field Safety Notice (FSN), which lists affected batch numbers. Advise patients to contact Novo Nordisk directly on the Customer Care line on 0845 600 5055 or to use the manufacturer’s website to check if their device is affected and request a replacement cartridge holder. Ensure user is able to maintain insulin regime via a suitable device or alternative method. Discontinue supply of affected devices. If patients have any questions or concerns, they should contact their doctor, pharmacist or Novo Nordisk’s Customer Care line on 0845 600 5055. All healthcare professionals should contact Alloga on 01773 515124 to arrange replacements and return affected stock.

Device

Insulin pens
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Examples of where to find the batch numbers on the NovoPen Echo and NovoPen 5 are included in the document MDA/2017/024 - Insulin pens: NovoPen Echo and NovoPen 5 (certain batches).The list of affected batch numbers is in the FSN.
  • Manufacturer
    Novo Nordisk

Manufacturer

Novo Nordisk
  • 제조사 주소
    Dr Avideh Nazeri Director of Clinical, Medical and Regulatory Novo Nordisk Ltd 3 City Place Beehive Ring Road Gatwick West Sussex RH6 0PATel: 01293 613 555CustomerCare@novonordisk.com
  • 제조사 모회사 (2017)
    Novo Nordisk A/S
  • Source
    MHRA