Events

Alerte De Sécurité sur Etest PIP/TAZO/CON‐4 PTC 256

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par bioMérieux.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-11-27
  • Date de publication de l'événement
    2015-11-27
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151127a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: biomérieux etest pip/tazo/con‐4 ptc 256 medical device manufacturer, biomérieux, has issued a medical device safety alert concerning its etest pip/tazo/con‐4 ptc 256. [product reference numbers: 412434, 412433, 521418 and 521458] based on a low minimum inhibitory concentration (mic) report from the field, the manufacturer initiated a complaint investigation (pr 929981) to confirm product performance and determine root cause. as a result of the investigation, the following was identified: isolates (enterbacteria strains) were tested with agar dilution and broth micro dilution reference method: using eucast breakpoints (mic< or =8: susceptible; mic>16: resistant), etest pip/tazo showed a higher frequency of erroneous results, false susceptible results, when comparing to the referenced method (broth-micro dilution). performance using clsi breakpoints (compared to broth micro dilution referenced method) was similar to eucast. in conclusion, the data analysis demonstrates that the etest piperacillin/tazobactam performance has shifted when compared to the published performance characteristics. according to the manufacturer, the risk to patients as a result of the etest pip/tazo/con‐4 ptc 256 performance shift is the potential for reporting erroneous results for piperacillin/tazobactam; specifically false susceptible results. this risk may lead to medical intervention for the patient because the erroneous result could negatively influence the selection of antibiotic therapy. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 november 2015.

Device

Etest PIP/TAZO/CON‐4 PTC 256

Manufacturer

bioMérieux