Events

Field Safety Notices about cobas c 111 analyzer

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
  • 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
    We have become aware of a software issue that may lead to erroneous results on cobas c 111 analyzer (without ise unit) in very rare cases. cobas c 111 analyzer with ise unit are not affected as long as the ise is in status ‘ready’. to date, no field issue has been reported where the identified software error actually produced wrong results. under very rare constellations of already used and unused cuvettes remaining on the cobas c 111 analyzer rotor a measurement timing error “7002: 108000572 a software error occurred” might be produced. immediately after occurrence of the error all ongoing tests are stopped. depending on open test orders the system might restart processing using an already consumed cuvette and hence, producing a potentially erroneous result. we have identified measures to ensure the detectability for measurements that may have yielded erroneous results. .

Device

cobas c 111 analyzer
  • Model / Serial
  • Manufacturer
    Roche

Manufacturer

Roche