Events

Avis De Sécurité sur ADVIA Chemistry System

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par SIEMENS HEALTHCARE DIAGNOSTICS INC..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2013-09-17
  • Date de publication de l'événement
    2013-04-10
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2013/10/04/vazno-obavestenje-o-medicinskom-sredstvu-advia-chemistry-system-model-1200-1800-2400-biohemijski-analizator/
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ALIMSA