Events

Recall of AQURE data management system

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Radiometer Pacific 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-2016-RN-00015-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00015-2
  • 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
    There is a potential clinical issue with aqure if the data management system is being used to interpret patient results for the management of treatment. the issue occurs when a sample type is not provided from a device. an example is where results from a sample type of “urine” (not displayed) are compared to results from a sample type “arterial”. in this case a clinician may incorrectly take action based on an assumption that all results are from a sample type “arterial”. this may lead to wrongful diagnosis and wrongful treatment of the patient which can result in immediate as well as long term critical health consequences for the patient.
  • Action
    The sponsor will contact the affected customers to arrange for the installation of a database script which will mitigate the risk as a temporary measure. A final solution involving a software upgrade will be provided to the customers when it becomes available. In the meantime, the AQURE system can continue to be used but users are advised to interpret blank fields for sample type as "not specified".

Device

AQURE data management system

Manufacturer

Radiometer Pacific Pty Ltd