GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 A. Menarini Diagnostics S.r.l. 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(09)
  • 날짜
    2013-08-20
  • 사례 국가
  • 사례 출처
    HPRA
  • 사례 출처 URL
  • 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 of glucomen lx sensor blood glucose test strips have been subject to a manufacturing fault and may give erroneously high blood glucose results, potentially leading to inappropriate insulin administration.
  • 조치
    Advice for End Users / Patients:  1. Identify, discontinue use and quarantine devices from the affected lot.  2. Return any devices from the affected lot to your pharmacy or distributor. Alternatively, contact A. Menarini Diagnostics (UK) or Medicon Ireland to arrange for return of any devices from the affected lot.  3. 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.  Advice for Healthcare Professionals / Pharmacists / Distributors:  1. Identify, discontinue distribution and quarantine devices from the affected lot.  2. Return any devices from the affected lot to your distributor. Alternatively, contact A. Menarini Diagnostics (UK) or Medicon Ireland to arrange for return of any devices from the affected lot.  3. Please also pass this notice on to any end user or organisation where the potentially affected devices have been transferred or who are using the GlucoMen LX and GlucoMen LX PLUS meters.  4. Ensure that the appropriate personnel and end users are made aware of this notice.  5. Ensure that end users who return blood glucose test strips from the affected lots can continue to appropriately monitor their blood glucose.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter
  • Manufacturer

Manufacturer