Events

Recall of RAPIDPoint 500 Blood Gas Analyser with V2.4 Software

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare 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-00499-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00499-1
  • 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
    Siemens healthcare diagnostics has identified an issue with rapidpoint 500 blood gas analysers with v2.4 software. there is a potential to misassign patient demographic information (last name, first name, gender, or date of birth) when the patient id field is left “blank” on multiple patient samples and a recall of the patient information is initiated. as stated in the rapidpoint 500 operators guide, the patient id field is a “required” field, and the patient id field is set as “required” when the rapidpoint 500 analyser is shipped from siemens. there is a risk to health based upon the potential misclassification of a patient as having falsely abnormal test results receiving additional diagnostic testing and treatment, as well as the risk of a patient who has abnormal results being incorrectly identified as having normal results based upon incorrect sample identification.
  • Action
    Siemens Healthcare is currently developing a software update to address this issue and will be providing new information as it becomes available. In the interim, Siemens is advising users to maintain the Patient ID field as enabled and a “required” Patient Demographic entry on their RAPIDPoint 500 analyser. If the Patient ID field on the RAPIDPoint 500 analyser is not set as “required,” reset it to “required” by following the instructions provided in the customer letter. If the laboratory has run samples from multiple patients with the Patient ID field blank, Siemens recommends a review of those previously generated results.

Device

RAPIDPoint 500 Blood Gas Analyser with V2.4 Software
  • Model / Serial
    RAPIDPoint 500 Blood Gas Analyser with V2.4 SoftwareSiemens Material Numbers (SMN): 10492730, 10696857, 10697306ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA