Events

Rappel de RAPIDLab 1260/1265 Systems. An in vitro diagnostic medical device (IVD)

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 Ltd Diagnostics Division.

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-2015-RN-00416-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-15
  • 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-2015-RN-00416-1
  • 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
    The analyzers will potentially not indicate the error codes below: error code: d50 glucose sensor errorproblem: the system detects an open connection in the glucose biosensorerror code: d51 lactate sensor errorproblem: the system detects an open connection in the lactate biosensor.If the error codes were functioning properly, glucose or lactate results would be suppressed in the presence of their respective code. while a disconnected glucose sensor could result in falsely elevated or depressed glucose values, the risk is limited to a falsely elevated glucose result that could potentially lead to a missed or delayed diagnosis of hypoglycemia requiring intervention. while a disconnected lactate sensor could result in falsely elevated or depressed lactate values, the primary risk is limited to a falsely depressed result that could potentially lead to a missed/delayed diagnosisand/or an inaccurate evaluation of the severity of sepsis, ischaemic and hypoxic conditions.
  • Action
    A look-back of previous results is at the discretion of the laboratory. A new software version for the RAPIDLab 1260 and RAPIDLab 1265 analyzers is being developed to address this issue, and will be provided by Siemens as soon as it is available. In the interim, users are advised to ensure that the Glucose and Lactate sensor contacts are aligned and completely seated with the contacts on the analyzer and analyze a minimum of 2 levels of quality control material after installing the sensors, as indicated in the RAPIDLab 1200 Operator’s Guide.

Device

RAPIDLab 1260/1265 Systems. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    RAPIDLab 1260/1265 Systems. An in vitro diagnostic medical device (IVD)RAPIDLab 1260 Blood Gas AnalyzerSiemens Material Numbers:10321846, 10491394, 10339910 RAPIDLab 1265 Blood Gas AnalyzerSiemens Material Numbers: 10321852, 10470366, 10491395, 10335524ARTG number: 175890
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA