Events

Field Safety Notices about Dimension®, Dimension Vista®

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 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.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-04-12
  • 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 confirmed that dimension tni and dimension vista digxn, e2, ferr, prl, tsh operating instructions (ifu) under the non-interfering substances section of the biotin concentration unit are incorrect, indicating a concentration level at which biotin does not constitute interference. in the case of tni, e2, ferr, prl and tsh, biotin represents a significant interference at the indicated concentration. in the case of the dimension vista e2, which is a competitive test, biotin interference shows a positive deviation, while in the other tests (sandwich methods) it shows a negative deviation.

Device

Dimension®, Dimension Vista®
  • Model / Serial
    Dimension Troponin I (TNI) RF621 10464525 All lot numbers up to update Operating Instructions (IFU) Dimension Vista Digoxin (DIGXN) K6435 10488927 All lot numbers up to update Operating Instructions (IFU) Dimension Vista Estradiol (E2) K6463 10489099 All lot numbers up to update Operating Instructions (IFU) Dimension Vista Ferritin (FERR) K6440 10445136 All lot numbers up to update Operating Instructions (IFU) Dimension Vista Prolactin (PRL) K6462 10488398
  • Manufacturer
    Siemens Healthcare d.o.o.

Manufacturer

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