Events

Negative Combo Panel 50; Negative Panel Urine 51; ESBL Confirmation Panel Microscan ESBL Plus; MIC Type 38 Negative Panel; Negative Panel Urine Combo Type 55. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostic Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1456
  • 날짜
    2014-11-11
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    The effect is the potential for minor clinical categorical errors for isolates of P. mirabilis and Imipenem if the new cut-off points are implemented and used in conjunction with the types of panels listed in Table 1 (see Letter to Customer). There are no other results for antimicrobials affected. This question is not specific to the batch of panels, nor is it related to a particular reading method (eg WalkAway®, autoSCAN®-4, or manual reading). Additional information: check the Letter to the Client at: http://portal.anvisa.gov.br/wps/wcm/connect/0fd9d800462a68d1bc38bfec1b28f937/Security+Security+Notification. pdf? MOD = AJPERES
  • 원인
    The technical support bulletin 190, previously made available on the company's international website, included the interpretive and revised criteria of the clinical and laboratory standardization institute (clsi) m100-s20. however, the limited performance of siemens microscan dry gram negative panels for proteus mirabilis and imipenem was not mentioned in the bulletin when using the interpretive criteria reviewed by clsi m100-s20. the performance limitation resulted in minor errors for proteus mirabilis with imipenem when compared to the frozen reference method. therefore, the drug name, cim and interpretation should not be reported for p. mirabilis and imipenem for the cim / combo microscan negative gram dry panels.
  • 조치
    Actions to be Taken by the Client: 1. Confirm receipt of this letter. Please complete the attached "Effectiveness Verification Form" and send it by e-mail to Siemens Healthcare Diagnostics; 2. TSB 190 has been filed in the Siemens Document Library. If you have a copy, please dispose of it properly; 3. If your laboratory has implemented the revised Imipenem breakpoints, the imipenem should be deleted for the reports for P. mirabilis in the panels listed in Table 1 (Customer Letter); 4. If a TSA Action and Interpretation Alert Rule was created in your LabPro system following the instructions in TSB 190, all results for P. mirabilis and Imipenem using the Gram negative Negative panels listed in Table 1 should be suppressed using the instructions on the following pages.

Device

Negative Combo Panel 50; Negative Panel Urine 51; ESBL Confirmation Panel Microscan ESBL Plus; MI...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostic Inc