Events

Rappel de Dimension Vista V-LYTE Integrated Multisensor (used for measuring Na+/K+/Cl). 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 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-2016-RN-01652-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-21
  • 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-2016-RN-01652-1
  • 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 confirmed a low bias for dimension vista v-lyte integrated multisensor urine potassium (k) when compared to the dimension quiklyte integrated multisensor, which is the predicate device used in the method comparison section of the v-lyte instructions for use (ifu). testing by siemens showed a bias of -4.9% at a urine potassium concentration of 39.6 mmol/l, -19.6% at a urine potassium concentration of 32.8 mmol/l, and an average bias of -10.9% over the urine potassium concentration range of 7.5 to 133.7 mmol/l. this bias affects patient results, qc and could result in failures in accuracy-based proficiency testing programs. the risk to health as a result of the bias is negligible.Serum/plasma potassium results are not affected by this issue as there are separate parameters for serum/plasma potassium.
  • Action
    Siemens will be updating the internal coefficients for urine potassium in a future version of the Dimension Vista software. In the interim, Siemens recommends entering the following comparison coefficients for urine potassium to compensate for the observed bias: Urine Potassium: C0 = -1.03, Urine Potassium: C1 = 1.14. These correlation factors are to be applied for urine samples only. Siemens is not recommending a review of previously generated results.

Device

Dimension Vista V-LYTE Integrated Multisensor (used for measuring Na+/K+/Cl). An in vitro diagnos...
  • Modèle / numéro de série
    Dimension Vista V-LYTE Integrated Multisensor (used for measuring Na+/K+/Cl). An in vitro diagnostic medical device (IVD).Siemens Material Number (SMN): 10484429Catalogue Number: K800ALot Numbers: All in-date lots (including future lots until further notice)ARTG number: 181686
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA