Events

NON-SPECIFIC SYSTEMS FOR GLYCOSIS - MEASURING DEVICES AND RIBBON TESTS OF GLYCOSYDYDROGENASE WITH PYRROLOQUINONE QUINONE (GDH-PQQ) from all manufacturers. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 N/A 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
    992
  • 날짜
    2009-10-08
  • 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
    Non-glucose sugars capable of interfering with the GDH-PQQ reagent strips may appear in biological products and medicinal products or may result from the metabolism of another product. GDH-PQQ reagent strips do not distinguish glucose from other sugars. Of the 13 deaths due to excessive insulin administration in the United States, reported to the FDA between 1997 and 2009 involving this problem, some indicated hypoglycemia, confusion, neurological deterioration, severe hypoxia, brain damage and or coma before death. Sugar products other than glucose involved in these reports include Extranel (icodextrin), Potacor R, Octagam and an infusion containing maltose. More products may interfere with the results: Orencia (Abatacept), Gamimune N 5%, WinRho SDF Liquid, Vaccine Immune Globulin Intravenous (human), HepaGam N, Bexxat (radioimmunotherapy agent) Adept adhesion reduction solution (4% icodextrin) and any product which contains or is metabolized in maltose, galactose or xylose. No occurrences have been reported in Brazil until the present date.
  • 원인
    The fda, through studies from 1997 to 2009, reports that the use of glucose dehydrogenase reagent strips with pyrroloquinoline quinone (gdh-pqq) in health units, in patient blood samples containing certain sugars other than glucose (eg maltose, xylose, galactose), may produce false high glucose results, which may indicate a clinical measure. this problem may cause inappropriate dosing and administration of insulin, possibly resulting in hypoglycemia, coma, or death. such a problem may also mask true hypoglycemia if the patient and the health care provider rely solely on the measurement results with gdh-pqq glucose reactant tapes.
  • 조치
    Recommendations to users are as follows: (1) Avoid the use of GDH-PQQ reagent tapes in health facilities performing peritoneal dialysis; (2) If your health care facility uses GDH-PQQ reagent tapes, do not use them in patients who are receiving interfering products or patients whom you can not obtain information about using concomitant medications (eg patients non-responsive, patients unable to communicate); (3) Check, at the time of admission and periodically during hospitalization, whether patients are receiving incompatible products; (4) Inform staff and patients of the potential for false high readings in the presence of certain sugars other than glucose with GDH-PQQ reagent tapes; (5) Consider implementing drug interaction alerts in computerized patient record systems, charts, and patient charts to alert staff to the potential for false high glucose results; (6) Periodically check the results of the glycosimeter with laboratory tests. (7) Notify the National Health Surveillance System of any problems occurring in your health facility.

Device

NON-SPECIFIC SYSTEMS FOR GLYCOSIS - MEASURING DEVICES AND RIBBON TESTS OF GLYCOSYDYDROGENASE WITH...
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA