Events

Accu-Chek Connect Application Technical Name: Accu-Chek Connect Application Registration Number ANVISA: Risk Class: Affected Model: Version 1.2.0, 1.2.2 and 2.0.0 (iOS and Android) Serial Numbers Affected: Required update of Accu-Chek Connect Application 1.2.0, 1.2.2, 2.0.0 (iOS and Android) to ensure correct Correction Bolus suggestion. 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
    2152
  • 날짜
    2017-01-05
  • 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
    If you are using versions 1.2.0, 1.2.2 or 2.0.0 of the Accu-Chek Connect application for iOS or Android, please follow the following instructions: 1) Back up your data, 2) Stop immediately 3) Download and install the latest version of the app (1.2.3 or higher) available on the Apple App Store or Play Store on Android. This will correct the problem and prevent it from occurring in the future. All other versions of the Accu-Chek Connect Application not mentioned, as well as other Accu-Chek products that use the bolus calculator, are not affected. #### UPDATED ON 11/21/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • 원인
    We recently discovered a software problem in the accu-chek connect application versions 1.2.0, 1.2.2 and 2.0.0 that under certain conditions the history of bolus suggestions may have been affected by directly interfering with the current suggestion presented, as it may not consider the current active insulin referring to a previous bolus suggestion. another error may occur in cases where there is more than one monitor paired with the same application on the iphone (ios) operating system. in rare circumstances, after the glucose test the application may not suggest the correction bolus at the correct interval (10 to 15 minutes). depending on the patient's metabolic status, an incorrect bolus suggestion can lead to serious health problems such as hypoglycemia if the bolus suggestion function erroneously recommends a high dose of insulin. this may also cause the amount of active insulin displayed on the display to be incorrect.
  • 조치
    Field Action Code SBN_RDC_2016_14 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

Accu-Chek Connect Application Technical Name: Accu-Chek Connect Application Registration Number A...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH