Events

Flex Reagent for HB1C Glycosylated Hemoglobin Dimension, Cartridges (6 x 20) + Calibrators (5 x 2mL) - Registration 10345161815. - Batches GA4266; BA4273; BA4280; BA4287; GA4301; GA4315; GC4322; GA4343; GA4350; GA4357; GA5013; GA5020 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos Ltda. 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
    1446
  • 날짜
    2014-10-21
  • 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 monitoring of patients with hyperglycemia depends on diet, lifestyle, glucose concentrations, HBA1c and adjustments of therapies for glycemic control. A positive bias of up to 1.0% [11 mmol / mol] for HbA1c may be considered clinically significant at relevant values ​​and may result in modification of therapy for hyperglycemia. Modification of hyperglycemia therapy may increase the risk of hypoglycaemia, which can be observed by monitoring the patient's blood glucose and / or symptoms.
  • 원인
    Siemens has confirmed that the dimension® hb1c flex® kit for lots ga4266; ba4273; ba4280; ba4287; ga4301; ga4315; gc4322; ga4343; ga4350; ga4357; ga5013 and ga5020 present a mean positive bias of 0.4% [4.4 mmol / mol] in hemoglobin a1c and occasionally 1.0% [11 mmol / mol] in hba1c for patients compared to the national glycohemoglobin standardization program (ngsp). controls can display the same performance. depending on the quality control limits, this problem may not have been detected.
  • 조치
    The company advises customers to discontinue use of the product, segregate any remaining stock from the affected lot of the HB1C Dimension Glycosylated Hemoglobin Flex Reagent in order to return these products to Siemens and to keep the letter with the laboratory records.

Device

Flex Reagent for HB1C Glycosylated Hemoglobin Dimension, Cartridges (6 x 20) + Calibrators (5 x 2...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.