Events

Recall of AQURE Data Management System, Version 1.54. An in vitro diagnostic medical device (IVD)

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-2013-RN-01318-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01318-1
  • 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
    Results which are repressed on the analyser are shown in aqure version 1.5.4 and forwarded to the his/lis. repression means that values flagged with errors (marked with "?") are not displayed on the analyser. the repressed results are forwarded to aqure and flagged, but dependant on the settings of the hospital it, the result may not be flagged in his/lis. the problem is present when the user has enabled the option 'repress results' on the analyser and uses aqure version 1.5.4.The results may not be flagged in his/lis and the user will therefore not be aware that the result may be incorrect. patient treatment or diagnosis could therefore be based on an incorrect result.An example:the abl90 analyser did not give a cl- result due to the error 1227 "correction for bicarbonate contains errors from ph, pco2". however the chloride result was displayed in the following way:on the analyser: blank (no value) and "?"aqure: 100mmol/l with "?" and highlighted redhis/lis: 100mmol/l.
  • Action
    Radiometer is configuring the database of the AQURE system to ensure that all "?" marked results are blanked in AQURE and prior to transmitting to the HIS/LIS. Radiometer recommends a review of previous patient results with repressed parameter values in AQURE and HIS/LIS.

Device

AQURE Data Management System, Version 1.54. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    AQURE Data Management System, Version 1.54. An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd