Events

ESTRADIOL IMMULITE 2000, model Kit for 200 tests; kit for 600 tests, class II, registration 10345160699, batch / series: Kit for 200 tests: 282; 283; 288; 290; 291; 294; 301; 302; 303; 305; 307; 308; 310; 311; 313; 314; 316; 317; 318; 320; 321; 322; 323; 325; 327; 328; 329; 332; 333; 334; 335; 337; 338; 340; 342; 343; 344; 345; 346; 347; 348; 349; 350; 351; 353; 354; 355; 357; 358; 360; 361; 362; 363; 364; 369. Kit for 600 tests: 282; 287; 290; 292; 293; 296; 297; 298; 303; 304; 305; 306; 309; 310; 313; 314; 316; 317; 320; 322; 323; 324; 326; 327; 329; 332; 333; 336; 338; 339; 342; 345; 347; 349; 350; 351; 353; 354; 356; 357; 361; 363; 364; 368; 369. /// ESTRADIOL - IMMULITE, model Kit for 100 tests, risk class II, registration 10345160711, lot / series: 332; 333; 335; 336; 337; 338; 339; 340; 341; 342; 343; 344; 345; 346; 347; 348; 350; 351; 352; 353; 354; 355; 358; 359; 360. /// ADVIA Centaur Enhanced Estradiol (eE2), model 100 tests; 500 tests, hazard class II, registration 10345161769, lot / series: 72030; 3575030; 11759018; 13170018; 13207031; 15117018; 18408031; 18426020; 19481020; 21058020; 23802021; 24639021; 28107022; 28194022; 31117023; 32682023; 35283024; 36441024; 37859024; 38443024; 39467025; 40609025; 4,151,3025; 4,250,5025; 4,417,5026; 4,483,5026; 4,634,026; 4,714,6026; 4,990,927; 5,088,9027; 5,287,7027; 5,336,2029; 5,438,5029; 5,543,9029; 7,755,9029; 2,850,3011; 82073011; 83233012; 87765014; 89433014; 89736030; 93183016; 95235017; 97087017; 97945017. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Products Ltd.; Siemens Healthcare Diagnostics 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
    1800
  • 날짜
    2016-01-16
  • 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 health risk applies to all patients receiving fulvestrant. Cross-reaction may lead to falsely elevated estradiol results leading to an inappropriate clinical evaluation of estrogen status. Fulvestrant is used in the treatment of postmenopausal women in the recurrence of stage IV breast cancer positive for estrogen receptor. If the listed estradiol trials are used to assess the menopausal status of a given patient population, falsely elevated estradiol levels may lead the clinician to misinterpret this patient as premenopausal, possibly leading to altered use or even discontinuation of drug use potentially beneficial, or fulvestrant. If this has occurred, reassessing the patient's menopausal status by other means or using an alternative estradiol measure may be considered.
  • 원인
    Possibility of falsely elevated estradiol results due to cross-reactivity of fulvestrant in the estradiol assays of siemens healthcare diagnostics.
  • 조치
    The field action code CC 16-03 initiated by Siemens addresses the sending of a Letter to the Client with risk classification II (situation in which there is a high probability that the use or exposure to a health product may cause a temporary health or reversible per treatment). Recommendation to users and patients: Because of the significant interference of fulvestrant with estradiol immunoassays, these assays should not be used for the monitoring of estradiol levels in patients receiving fulvestrant. For patients being treated with fulvestrant, the use of an alternative method such as Mass Spectrometry (LC-MS), which is expected to not be cross-reacted with fulvestrant, should be used to estradiol. Siemens oestradiol trials may continue to be used to report results from patients not on fulvestrant therapy.

Device

ESTRADIOL IMMULITE 2000, model Kit for 200 tests; kit for 600 tests, class II, registration 10345...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Products Ltd.; Siemens Health...