Events

Alerte Ou Avis De Sécurité sur Accu-Chek Compact meter and test strips, Accu-Chek Mobile meter and test cassette, Accu-Chek Active meter and test strips

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 Roche.

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/2014/026
  • Numéro de l'événement
    CON433897
  • Date
    2014-07-09
  • Date de publication de l'événement
    2014-07-09
  • 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/CON433897?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 accu-chek compact, accu-chek mobile and accu-chek active devices may give falsely low blood glucose readings for patients receiving ceftriaxone therapy. roche has updated product leaflets for these devices and issued a field safety notice (fsn), distributed to healthcare professionals.
  • Action
    Identify diabetic patients on ceftriaxone therapy. Advise these patients and relevant healthcare staff not to use Accu-Chek Compact, Accu-Chek Mobile or Accu-Chek Active devices throughout the duration of treatment with ceftriaxone. Ensure that patients on ceftriaxone therapy use an alternative device during their treatment.

Device

Accu-Chek Compact meter and test strips, Accu-Chek Mobile meter and test cassette, Accu-Chek Acti...
  • Modèle / numéro de série
  • Description du dispositif
    Home use blood glucose meters: Accu-Chek Compact meter and test strips Accu-Chek Mobile meter and test cassette Accu-Chek Active meter and test strips manufactured by Roche.
  • Manufacturer
    Roche

Manufacturer

Roche