Events

Field Safety Notices about Multiplate 5.0 – Platelet Function Analyzer

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Roche Diagnostics GmbH.

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
    2016-12-21
  • Event Date Posted
    2017-02-03
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2017/03/02/obavestenje-o-medicinskom-sredstvu-multiplate-5-0-platelet-function-analyzer/
  • 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
    Multiplate® analyzer software includes a feature that allows the reference range and target range to be displayed as horizontal bar graphs. when enabled, the sample result will be displayed as a black vertical line within the reference / target range of the graphics bars, to show its position relative to the set ranges. when the sample results are printed, the bars and lines of the sample results will also be printed. normally, the print settings for paper size and orientation are set to a4 and portrait. when the end user changes the print setting to a paper size other than the "a4" format and the landscape, the position of the result line shown within the reference and target range graph bar may be incorrect. the misrepresentation of the line of results and reference and target ranges is due to a software error, which will be corrected with a new software release, whose release is expected for the second quarter of 2017. this problem only occurs when the result is printed immediately after measuring the result. printing results using archived results does not cause this problem. in clinical situations, accurate data by numerical results and accurate visual presentation of results is essential, and failures can lead to medical risks for the patient.

Device

Multiplate 5.0 – Platelet Function Analyzer

Manufacturer

Roche Diagnostics GmbH