Events

FreeStyle Lite® Test Strips 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Abbott Diabetes Care 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
    Field Safety Notice
  • 사례 연번
    SN2013(14)
  • 날짜
    2013-12-04
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/freestyle-lite-test-strips&id=8496f825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • 데이터 추가 비고
  • 원인
    The irish medicines board (imb) has been notified that certain lots (lot numbers 1284962 and 1372611) of freestyle lite® blood glucose test strips may give erroneously low blood glucose results and may produce out of range control solution results when using freestyle® blood glucose meters, freestyle mini® blood glucose meters and the freestyle® meter built into the omnipod® system.
  • 조치
    Advice for End Users / Patients:  1. Identify any test strips from the affected lots.  2. Follow the manufacturer’s instructions outlined in the attached field safety notices (FSNs).  3. Discontinue use and dispose of test strips from the affected lots and contact Abbott Diabetes Care Customer Service on 008000 2255 232 or 1800 776633 for a replacement of the affected test strips.  4. Ensure that you can continue to appropriately monitor your blood glucose via test strips from a different lot number or by other means. This should be done in consultation with your healthcare professional.  • Pay special attention to signs and symptoms of high blood sugar (hyperglycemia).  • Symptoms of high blood sugar may include: Excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.  Advice for Healthcare Professionals / Pharmacists / Distributors:  1. Identify any test strips from the affected lots.  2. Follow the manufacturer’s instructions outlined in the attached field safety notices (FSNs).  3. Discontinue use and dispose of test strips from the affected lots and contact Abbott Diabetes Care Customer Service on 1800 776633 for a replacement of the affected test strips.  4. Ensure that the appropriate personnel are made aware of this notice and the attached field safety notices. Please also pass this notice and the attached FSNs on to any end user or organisation where the potentially affected test strips have been transferred.  5. Ensure that end users who dispose of blood glucose test strips from the affected lots can continue to appropriately monitor their blood glucose.

Device

FreeStyle Lite® Test Strips

Manufacturer

Abbott Diabetes Care
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HPRA