Events

Accu-Chek Connect Diabetes Management App for iPhone (iOS) v1.2.0(.5) (used in conjunction with Roche Accu-Chek Avica Connect and Accu-Chek Guide Blood Glucose Meters). 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-2016-RN-01168-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-09-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01168-1
  • 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 diabetes care has identified a programming error in the accu-chek connect diabetes management app ios version 1.2.0(.5) which under certain conditions could potentially lead to an inaccurate bolus insulin advice being provided to the patients. as a result of this issue the app “lightbulb” icon is not displayed and the correction bolus advice is not available.. the blood glucose (bg) value which could not be used initially may unintentionally become available for bolus advice calculation at a later time. if the patients then request a bolus advice for a bg value older than 10 minutes without taking and transferring a new bg measurement, it could lead to an incorrect bolus insulin recommendation. depending on the actual metabolic situation a potentially incorrect bolus advice could lead to serious health consequences.
  • 조치
    Roche is advising Health Care Professionals to inform their patients by distributing a copy of the letter, to whom the Accu-Chek Connect diabetes management app has been distributed. Patients are being advised to discontinue using version 1.2.0.5 and update their app immediately to version 1.2.2.2. This action has been closed-out on 12/05/2017.

Device

Accu-Chek Connect Diabetes Management App for iPhone (iOS) v1.2.0(.5) (used in conjunction with R...

Manufacturer

Roche Diabetes Care Australia Pty Ltd