Events

Recall of RAPIDPoint 400 Series, RAPIDPoint 500, and RAPIDLab 1200 Series Analysers (diagnostic blood gas analyser)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd Diagnostics Division.

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-01001-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-09-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01001-1
  • 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
    According to reports received by siemens, users can inadvertently enter a wrong patient id on the demographics screen, which ultimately could lead to a misidentification of the sample. patient id mismatches could be caused by the following:1. inadvertently accepting the pre-selected patient id on the demographics screen.2. overwriting sample demographics by incorrect operation of the patient list button.3. scanning the wrong barcode.4. manually typing the wrong barcode.In each of these cases, failure to check the correct demographics before moving on to the results screen will assign the wrong demographics to the sample being tested.
  • Action
    Siemens is providing work around instructions for users to follow in the event that patient ID mismatch occurs. A software update will be available for RAPIDPoint 400 series and RAPIDPoint 500 analysers in January 2014. Software version 3.2 and over which are currently available for RAPIDLab 1200 Series analyser addresses the issues. This action has been closed-out on 28/04/2016.

Device

RAPIDPoint 400 Series, RAPIDPoint 500, and RAPIDLab 1200 Series Analysers (diagnostic blood gas a...
  • Model / Serial
    RAPIDPoint 400 Series, RAPIDPoint 500, and RAPIDLab 1200 Series Analysers (diagnostic blood gas analyser)ARTG Number: 174383
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA