Events

Field Safety Notices about ONLINE TDM Gentamicin assay

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 Roche Diagnostics.

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
    In the last version of this customer letter we informed you about the implementation of an instrument factor (if) for online tdm gentamicin that was - based on available data - the mitigation for the reported issue. however, against initial data the correction of the instrument factor did not mitigate the issue. we received complaints from customers who implemented the if, observing decreased sample recovery using the online tdm gentamicin assay. since availability of fresh patient samples for gentamicin is very limited, frozen patient samples had to be used for internal investigations. obviously, the internal results obtained with these samples and used for the implementation of the if did not match with the external observations reported by customers. further investigations were initiated at roche to understand this mismatch. in order to verify the internal results a new panel of patient samples was collected (panel b, stored at -80°c) and compared to the panel that was used for the determination of the if (panel a, stored at -20°c). .

Device

ONLINE TDM Gentamicin assay
  • Model / Serial
    04490843190 ONLINE TDM Gentamicin 100 Tests c 311, c 501/502 05841291190 ONLINE TDM Gentamicin 100 Tests c 701/702
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics