Events

Rappel de V-Lyte Dilution Check & V-Lyte Integrated Multisensor Technology (IMT). 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-2017-RN-00533-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-24
  • 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-00533-1
  • 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 two issues related to the v-lyte integrated multisensor technology (imt) system. the issues regarding the v-lyte dilution check solution and the v-lyte imt system are:1. dilution check relative bias failures - a high rate of dilution check relative bias failures of greater than 2% when using specific lots of v-lyte dilution check solution; and2. integrated multisensor (imt) urine sodium drift - elevated urine sodium quality control (qc) exceeding acceptable qc ranges with the dimension vista imt system. a greater urine sodium drift with urine qc than urine patient samples has been observed. however, not all imt sensors exhibit the described urine sodium qc drift.
  • Action
    1) For repeated dilution check relative bias failures, Siemens is advising users to contact Customer Care Centre for further assistance. 2) For repeated elevated urine sodium QC drifts, users are advised to load a new Integrated Multisensor Technology (IMT) sensor in addition to coordinating a combination of the steps detailed in the recall letter to minimise or eliminate the drift of urine sodium QC and patient samples as well as to prevent premature sensor replacement and additional troubleshooting. Users are requested to review the letter with their Medical Director.

Device

V-Lyte Dilution Check & V-Lyte Integrated Multisensor Technology (IMT). An in vitro diagnostic me...
  • Modèle / numéro de série
    V-Lyte Dilution Check & V-Lyte Integrated Multisensor Technology (IMT). An in vitro diagnostic medical device (IVD)V-Lyte Dilution CheckCatalogue Number: K840Material Number (SMN): 10445203Lot Numbers: KC6D01, KC6F01 & KC6J01 V-Lyte Integrated Multisensor Technology (IMT)Catalogue Number: K800AMaterial Number (SMN): 10484429Lot Numbers: 6KD875, 6KD877, 6MD882, 7AD886 & 7BD890 (& future lots until issue resolution)ARTG Number: 181686
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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