Events

Rappel de RAPIDPoint 500 Blood Gas Analyser with V2.4 Software

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Healthcare Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00499-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-26
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00499-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA