Events

Alerte Ou Avis De Sécurité sur Accu-Chek Mobile meter and Accu-Chek Mobile test cassette

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/2014/021
  • Numéro de l'événement
    CON425103
  • 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/CON425103?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
    This device may give falsely high readings. as a consequence, patients might take an inappropriately high dose of insulin. the meter uses strip-free technology so users need to follow a specific testing procedure that is different to standard meter and strip systems. roche has sent its field safety notice (fsn), with updated instructions, to registered patients, healthcare professionals, distributors and retailers. the instructions are also online: www.Accu-chek.Co.Uk/mobilepropertesting (external link) this meter has been distributed in the uk since 2010.
  • Action
    Identify patients who use these meters and advise them to follow the correct testing procedure, details of which have been provided in the FSN. Ensure that patients can continue to monitor their blood glucose. If patients are concerned about their blood glucose readings when using this meter, advise them to contact their healthcare professional.

Device

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

Manufacturer

Roche