Events

Accu-Chek Connect diabetes management app 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Roche Diabetes Care Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-00007-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-01-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00007-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Roche have identified two software issues with the accu-chek connect diabetes management app, v1.2.0, 1.2.2, 2.0.0 (ios & android). under certain conditions the affected versions may disregard historical bolus data potentially leading to an invalid bolus insulin recommendation being provided to the end user. additionally, it was discovered that pairing & using multiple meters with the ios version of the accu-chek connect app can, under rare circumstances cause the bolus advisor to fail to offer a blood glucose (bg) correction bolus recommendation within the eligible time window following a bg measurement (10 – 15 min). depending on a patient’s situation, a potentially incorrect bolus advice could lead to serious health consequences as e.G. a hypoglycaemia in case the impacted bolus advice function erroneously recommended a too high insulin dose. both issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect.
  • 조치
    Roche have released an update to the app with both issues described above corrected. In addition, Roche will be placing an alert on their website www.accu-chek.com.au informing patients to ensure they use the latest app version available on the Apple App or Google Play store (1.2.3).

Device

Accu-Chek Connect diabetes management app

Manufacturer

Roche Diabetes Care Australia Pty Ltd