Events

Field Safety Notices about Accu-Chek and CoaguChek

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Roche.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-01-26
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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