Events

Field Safety Notices about cobas e 411 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 regret to inform you that in very rare cases a software (sw) malfunction in the sample&control datafile can occur which may lead to a potential data mismatch. this sw malfunction only occurs: ∑ when the “sample data clear” function is not performed daily as indicated in the operator’s manual, and ∑ when the sample&control datafile of the cobas e 411 analyzer is filled with > 2000 records. all tests that are run on cobas e 411 are potentially affected whereas the impact of the data mismatch cannot be predicted. roche has received a total of four customer complaints for this issue. .

Device

cobas e 411 analyzer
  • Model / Serial
    cobas e 411 analyzer (disk system) (GMMI 04775279001) cobas e 411 analyzer (rack system) (GMMI 04775201001)
  • Manufacturer
    Roche

Manufacturer

Roche