Events

Avis De Sécurité sur Accu-Chek and CoaguChek

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia 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
    Field Safety Notice
  • Date
    2016-01-26
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Some accu-chek inform ii base units (bu) and handheld base units (hbu), used for coaguchek professional meters and cobas h232 meters, might produce transmission errors between the meter and the data management system (dms; e.G. cobas it 1000 or any other 3rd party software). the transmission errors present in the form of data loss. this could happen, in rare cases, when the bu/hbu is connected via a usb to a pc. if your bu/hbu is connected via ethernet or if you use wi-fi, you will not experience this issue. if your bu/hbu is connected to a pc via usb, the data loss may cause invalid data exchange. for example, in the case of the accu-chek inform ii meter, this is indicated by numerous messages sent from the meter to the dms in the form of “unexpected sw failure 11800” events. please note that the error message “unexpected sw failure 11800” is quite unspecific. it might have other causes and is therefore no clear indicator for the data loss. .

Device

Accu-Chek and CoaguChek
  • Modèle / numéro de série
    Accu-Chek Inform II Base Unit Handheld Base Unit Handheld Base Unit USA Roche HBU/BU Control Panel Accu-Chek Inform II meter+RF Accu-Chek Inform II meter cobas h 232 cobas h 232 scanner version CoaguChek XS Pro Int'l CoaguChek XS Pro USA CoaguChek XS Plus Int'l CoaguChek XS Plus Japan CoaguChek Pro II WLAN CoaguChek Pro II
  • Manufacturer
    Roche

Manufacturer

Roche