Events

Recall of AQURE Data Management System Software prior to version 1.8.2 may be affected.

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-2014-RN-00453-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00453-1
  • 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
    Radiometer has recently become aware of three potential issues with unit conversion in aqure that may occur if the device is transmitting in a different unit than aqure is displaying and/or transmitting to the his/lis. - conversion of ketone from mmol/l to mg/dl or vice versa: the parameter ketone is measured on either the siemens clinitek or the docureader. this is not applicable in australia as none of these devices are connected to aqure. - conversion of glucose and lactate from g/l to mmol/l or vice versa: in both cases a potential wrong conversion factor may be used, which may cause the reported result to be incorrect by a factor 10,000. this problem may be present in all versions of aqure.- converting from mg/dl to mg/l and g/dl to g/l or vice versa: a potential wrong conversion factor may be used of 1/10. the correct factor is 10. reported results may be incorrect by a factor 100. this problem is not parameter specific and may be present in all versions of aqure.
  • Action
    End users are requested to not change the units on AQURE or iSTAT without consulting Radiometer Pacific. Radiometer will be carrying out testing to identify affected software and a software update will be installed to correct the issue. This action has been closed-out on 29/01/2016.

Device

AQURE Data Management System Software prior to version 1.8.2 may be affected.
  • Model / Serial
    AQURE Data Management SystemSoftware prior to version 1.8.2 may be affected.
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd