Events

Insulin Infusion System, Registration: 10287410883, Serial Numbers - Annex I 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
    1571
  • 날짜
    2015-04-29
  • 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
    Although this possible loss of timing occurs rarely, if it does, the Accu-Chek Spirit Combo system will return to the original date and time settings and prompt the user to set or reschedule the correct date and time on the Accu-Chek Spirit Combo. In such cases, the user may accidentally go through this function without realizing and confirming the original date and time settings and leaving the established date and time settings provided by the Accu-Chek Spirit Combo. As a result, a change may occur in the block of time of the basal rate being delivered at that time, which may contribute to events of hyper or hypoglycemia. In particular, for the visually impaired, it may be difficult to detect the loss of date and time.
  • 원인
    Roche diabetes care has identified that in a small number of cases, the accu-chek spirit combo system may lose the date and time setting. the investigation has shown that this possible loss of date and time may occur when the accu-chek spirit combo capacitor does not function properly. the capacitor provides the power required to save the date and time settings during a power outage, for example during a battery change.
  • 조치
    To facilitate identification, Roche has sent users important information on how to replace the battery, as well as what is displayed on the pump display, in case of loss of the date and time setting (Annex II - letter with illustrative figures). Procedure for inserting and replacing the battery of your Accu-Chek® Spirit Combo SICI: Appendix II - enclosed letter with the illustrative figures (the information contained in our instruction manual). - Data storage time: The time and date remain stored in memory for approximately 1 hour after the battery is removed. The other settings of the Continuous Insulin Infusion System (SICI) (hourly basal rates, remaining cartridge content, bolus increment and active user menu) and event memory (bolus history, daily total insulin history, Temporary Basal Dose, alarm history) are stored regardless of the battery charge and the time your SICI has run out of battery power. The company also advises you to consult the instructions for use of your Accu-Chek Combo system. After introducing the new battery, SICI begins its self-test process. In case SICI does not start the self-test process after inserting the battery, make sure that it is inserted correctly. Please remember to replace the battery together with the new cover to have an ideal power supply for your SICI. Users who experience glitches associated with this issue can contact our Accu-Chek Response Center, and if the problem is identified, affected Accu-Chek Spirit Combo systems should be replaced. Roche Diabetes Care is addressing the issue and taking action to resolve it.

Device

Insulin Infusion System, Registration: 10287410883, Serial Numbers - Annex I

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH