Events

NordiPen® used with 5mg and 10mg Norditropin® SimpleXx® (‘somatropin’) and NordiPenMate® 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 ID
    MDA/2013/071
  • 사례 연번
    CON314666
  • 날짜
    2013-09-05
  • 사례 출판 날짜
    2013-09-05
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON314666?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
    There is a risk of under-dosing as the device may not fully screw together. a change to the metal screw threads of the mechanical section may cause the user to experience increased resistance during assembly.  patients may assume the pen is correctly assembled when it is not, and therefore not receive the correct dose. the manufacturer issued field safety notice (fsn) in july and september 2013 advising users of the problem and how to assemble the devices; however, they have received insufficient reconciliation data.
  • 조치
    Ensure that all staff who are responsible for managing patients with these devices are aware of the assembly instructions in the FSNs. Identify all patients who use these devices and ensure that they receive the patient letter attached to either FSN explaining how to assemble the devices. Return the confirmation of receipt form in the FSNs to the manufacturer.

Device

NordiPen® used with 5mg and 10mg Norditropin® SimpleXx® (‘somatropin’) and NordiPenMate®
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Growth hormone pens. NordiPen® used with 5mg and 10mg Norditropin® SimpleXx® (‘somatropin’) and NordiPenMate®. NordiPen® NordiPenMate® All devices with a lot number beginning with A or B. Lot numbers beginning with a ‘C’ are referred to in the July 2013 FSN but they were never distributed by the manufacturer. How to find the lot number The lot number is located on the mechanical section below the push button and can be exposed by turning the dose selector clockwise. The lot number in the example image begins with ‘B’.
  • Manufacturer
    Novo Nordisk

Manufacturer

Novo Nordisk