Events

Alerte Ou Avis De Sécurité sur Oxoid antimicrobial susceptibility testing discs (AST)

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Thermofisher Scientific.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2013/014
  • Numéro de l'événement
    CON251944
  • Date
    2013-03-20
  • Date de publication de l'événement
    2013-03-20
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON251944?tabName=allTabs
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer has issued nine field safety notices since november 2011 recalling batches of ast disc, due to the presence of non-impregnated or ‘blank’ ast discs manufactured before december 2012. ast discs may, therefore, not perform to the expected specification. blank discs could lead to a false indication of antibiotic resistance, which in turn could lead to delayed reporting, reduced options for treatment or unnecessary changes to treatment. recent recalls of oxoid ast discs have been in response to the potential for the presence of non-impregnated or ‘blank’ discs within specific disc lots. the manufacturer estimates that the rate of occurrence of blank discs is less than 1 in 100,000. there have been nine field safety notices on this issue since november 2011, with four occurring in february 2013.  more information can be found on the mhra website.
  • Action
    When reviewing results which do not fit the clinical picture (i.e. unexpected pattern of resistance within classes of antibiotic, discrepant results with MIC testing or unexpected patient outcomes on empirical therapy) consider if blank AST discs are a possible cause.   Consider the need for repeat and/or further testing of resistant isolates, including, where appropriate, non-disc methods,  especially in clinically severe cases and where there are reduced options for treatment due to high levels of resistance in your patients. Report any suspected examples of blank discs observed in your laboratory to the MHRA and the manufacturer. Medical microbiologists and microbiology laboratory managers.

Device

Oxoid antimicrobial susceptibility testing discs (AST)
  • Modèle / numéro de série
  • Description du dispositif
    Oxoid antimicrobial susceptibility testing discs (AST), manufactured by Thermofisher Scientific.
  • Manufacturer
    Thermofisher Scientific

Manufacturer

Thermofisher Scientific