Events

Field Safety Notices about Dimension® clinical chemistry system & Dimension Vista® System

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 Healthcare Diagnostics Inc..

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
    Siemens healthcare diagnostics has become aware of deferoxamine interference with dimension and dimension vista iron assays at a different concentration than listed in the instructions for use (ifu). deferoxamine is listed in the dimension and dimension vista ifu’s as a non-interfering substance. the concentration that was used for interference testing (250 ng/dl or 3.8 nmol/l) is significantly below what would be expected in clinical practice. siemens healthcare diagnostics is providing an update to the limitation of procedure section for the dimension and dimension vista iron assays instructions for use (ifu) to indicate that: patients treated with metal-binding drugs (e.G. deferoxamine) may have depressed iron values, as chelated iron may not properly react in the iron assay. .

Device

Dimension® clinical chemistry system & Dimension Vista® System

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS