Events

Field Safety Notices about ADVIA Chemistry System

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia 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
  • Date
    2013-09-17
  • Event Date Posted
    2013-04-10
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2013/10/04/vazno-obavestenje-o-medicinskom-sredstvu-advia-chemistry-system-model-1200-1800-2400-biohemijski-analizator/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    Siemens healthcare diagnostics manufactures field correction for advia 1200, 1650, 1800 and 2400 chemistry systems. the manufacturer has determined that these calculation test systems produce unmarked results when the results of the individual tests used in the calculation have labels. in cases where the marks suppress the numerical result, no calculation will be made. if a numerical result is generated with the tag, the calculation test will be issued without the tag. the results of the individual tests used to calculate the most common test ratios (eg anion gap, a / g ratio, osmolality and estimated ionized calcium) are of clinical significance and are commonly reviewed and released together with the result of the calculated ratio. however, the% hba1c_3 method can be set to produce only a score for the relationship, which means that if the tests included in the calculation are labeled, they will not be displayed on the end result, potentially leading to an inappropriate assessment of the patient's glucose control.

Device

ADVIA Chemistry System

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS INC.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ALIMSA