Events

Recall of Accu-Chek Connect diabetes management app

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diabetes Care Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00007-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00007-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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