Events

VITEK®2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 BioMérieux 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
  • 날짜
    2017-08-14
  • 사례 출판 날짜
    2017-08-14
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/vitek-2-identification-id-antimicrobial-susceptibility-test-ast-cards-potential-false-resistance-for-antibiotics-on-the-ast-panel-leading-to-false-negative-esbl-test-or-false-positive-urea-ure-reaction-on-id-cards
  • 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
    If moisture gets into the damaged test card pouches, it can stop the antibiotics working properly.The manufacturer’s investigation found that the root cause of the problem was a combination of stitch
    seal wheel design/positioning on the manufacturing equipment, and product shipping/handling. The stitch seal wheels on the manufacturing equipment have now been replaced with a new design.
  • 원인
    Manufactured by biomérieux – due to a manufacturing issue, some test card pouches might be damaged, resulting in antibiotic degradation.
  • 조치
    Ensure all relevant members of staff receive the manufacturer’s Field Safety Notice and that they understand the problem and the actions to be taken. Destroy any defective cards Contact Biomerieux to acknowledge receipt of the Field Safety Notice (dated 20 April 2017) even if you don’t have affected devices left in stock. Consider the need to repeat test if you observe any of the following results from the affected lots: a resistant imipenem result, particularly if unexpected and/or inconsistent with other results a resistant or intermediate nitrofurantoin result which is unusual or inconsistent with other results a resistant oxacillin or erythromycin result which is unusual or inconsistent with other results any quality control test result with these agents that is outside of the expected range If concerns exist after repeat testing, alternative methods of establishing drug susceptibility should be used As part of your review processes, report any incorrect results to MHRA

Device

VITEK®2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    All VITEK® 2 AST Test Cards manufactured before 16 March 2017 are affected.Images with examples of a defective pouch together with a spreadsheets of lot numbers and expiry dates of affected products is listed both in the manufacturer’s Field Safety Notice and in the pdf file attached to this alert at the bottom of the page.
  • Manufacturer
    BioMérieux

Manufacturer

BioMérieux
  • 제조사 주소
    Lena Duddell BioMérieux UK Limited Grafton House, Grafton Way Basingstoke, Hampshire RG22 6HY UKTelephone: 01256 461 881Email: lena.duddell@biomerieux.com
  • 제조사 모회사 (2017)
    Compagnie Merieux Alliance
  • Source
    MHRA