Events

cobas b 123 Sensor Cartridge BG / ISE / GLU / LAC, an integral part of the COBAS B 123 POC System equipment (Record 10287410948) - Affected Lots Distributed in Brazil: 21552191/21552491/21552591/21552692 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH 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
    1689
  • 날짜
    2015-09-18
  • 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
    Due to a potential risk of PCO2 interference in sodium (Na +) results in the specific batches of sensors, overestimated Na + results can be generated. The interference of PCO2 in Na + in patient samples causes potential risks only for patients with PCO2 increase, or with PCO2 at the upper end of the normal range. To date, there are no known cases where this issue caused any serious adverse events for patients.
  • 원인
    Roche diagnostics gmbh, the legal manufacturer of the products involved in this notification, during internal investigations, identified that specific batches of sensors called cobas b 123 sensor cartridge bg / ise / glu / lac, an integral part of the cobas b 123 system, exhibited pco2 interference in (na +) results in whole blood samples. the positive deviation in the sodium results increases with the pco2 values ​​(partial pressure of carbon dioxide) of the samples.
  • 조치
    The company recommends that - For measurement of the Na + parameter, unaffected batches of cobas b 123 Sensor Cartridges BG / ISE / GLU / LAC should be used. The affected batches are listed in Table 1 of the notification letter; all other batches, including subsequent batches, are not affected by this problem. - Whenever one of the affected batches listed in Table 1 of the Notification is used or is currently in use, one of the cobas b 123 Sensor Cartridges BG / ISE / GLU / LAC should be deactivated in order to avoid any risk of release too high sodium. For details on disabling Na +, see Appendix 1 of the Notification. -Alternatively, affected Cartridge sensors currently in use in the analyzer may be replaced by Non-Affected Batch Sensors. -The cobas b 123 Sensor Cartridges BG / ISE / GLU / LAC of affected batches not yet used can be discarded locally. - The replacement of affected lots may be requested from Roche Diagnóstica Brasil Ltda.

Device

cobas b 123 Sensor Cartridge BG / ISE / GLU / LAC, an integral part of the COBAS B 123 POC System...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH