Events

Field Safety Notices about RPD / ClinChem fully automated

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.

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
    2015-03-10
  • 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
    Customers complained about a 20% decrease in control levels when using non-roche controls (e.G. thermofisher liqimmune) with homocysteine reagent lot 697811 on cobas c 501. after changing to lot 604303, the controls were within range. the comparison of patient samples with reagent lot 697811 vs 604303 showed a bias of up to 54%. edta plasma samples were used. this negative bias could, in the worst case, lead to inaccurately low homocysteine results. however, it is unlikely that inaccurately low homocysteine results would lead to an immediate adverse event, since it has been demonstrated that homocysteine is a predictor of long-term (late cardiac events), rather than short-term cardiovascular risk. .

Device

RPD / ClinChem fully automated
  • Model / Serial
    05 385 415 190 Lot No.: 69781101 06 542 921 190 Lot No.: 69781401 05 385 377 190 Lot No.: 69780301
  • Manufacturer
    Roche

Manufacturer

Roche