Events

Field Safety Notices about ADVIA Centaur® XP

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 Siemens d.o.o..

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.

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  • Type of Event
    Field Safety Notice
  • Date
    2014-09-01
  • 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
    Siemens has determined that an error may occur when transferring patient demographics from the advia centaur xp analyzer to the lis. it has been found that in very rare cases, patient demographics from a previous order sent from the lis are transferred or attached to the next order. this problem can occur when the lis buffer in the advia centaur xp analyzer becomes full, and / or when a specific one character is found in the lis buffer in the last 5 positions. in this case, the patient's demographic information will be transferred to the lis and displayed on the advia centaur xp analyzer as well as on the printouts.

Device

ADVIA Centaur® XP

Manufacturer

Siemens d.o.o.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS