Events

Rappel de ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks. (used with the haemoglobin A1c_3 automated pre-treatment assay intended for monitoring long-term glycaemic control of persons with diabetes). 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-00983-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-25
  • 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-00983-1
  • 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 system also allows reporting in either ngsp units (hba1c% = %) or ifcc units (hba1cr = mmol/mol). the ratio equation used to calculate advia chemistry hemoglobin a1c_3 automated pretreatment (a1c_3) results in ifcc units contains an error. the error results in falsely depressed hba1cr results. available data indicates results may be depressed up to -62% (with an average of -18%). this issue does not impact hba1cr results using manual pre-treatment or ngsp units.Falsely depressed results may be considered clinically significant at clinically relevant hba1c values. the risk to health is limited to a potential misinterpretation of glycaemic control or a delay in assessing long-term average hyperglycaemia. when this issue occurs, the potential discordance between average glycaemia and falsely depressed hba1c values may be observed through personal glucose monitoring and/or patient symptoms.
  • Action
    Siemens is recommending retesting of patients with results above 35 mmol/mol that have been generated in the past 4 months and recommends discussing this issue with the laboratory director. Customers running the currently running the assay using Automated Pre-treatment and reporting results in IFCC units (mmol/mol) are advised to immediately discontinue reporting HbA1cR results. Siemens will be replacing the affected TDef disk with a corrected disk.

Device

ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks. (used with the haem...
  • Modèle / numéro de série
    ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks. (used with the haemoglobin A1c_3 automated pre-treatment assay intended for monitoring long-term glycaemic control of persons with diabetes). An in vitro diagnostic medical device (IVD).Siemens Material Numbers: 11127343 and 11222123ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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