Events

Safety Alert for Laboratory tests using biotin technology assay methodologies to promote binding with specific protein biomarkers.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2482
  • Date
    2018-02-08
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    Those companies that register for in vitro diagnostic products using Biotin technology assays should be aware of the interference of this substance in the results of the laboratory tests. Therefore, they should develop strategies to assess the need to take some action, including the communication of risk to their customers, changes in labeling or instructions for use. It should be noted that depending on the adopted measure, it may be necessary to notify ANVISA, according to RDC 23/2012. In addition, incorrect laboratory test results that have or have not caused an adverse event in the patient should be reported to ANVISA.//// To notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AEs) and complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    The us food and drug administration (fda) has published in its internet portal report that biotin (or vitamin b7) may interfere with laboratory test results, including the troponin test for the diagnosis of myocardial infarction . according to the document, biotin may lead to falsely high or falsely low results, depending on the test, thus impacting the diagnosis and consequently the patient's treatment. according to the fda, one patient died - with high levels of biotin - whose results from the troponin test were falsely low and, consequently, affected their treatment. the consumption of high levels of biotin is common through dietary supplements, as well as in some treatments for patients with pathologies, such as multiple sclerosis. it is possible that doctors are unaware of the patient's consumption of biotin, just as people may not know biotin is present in the dietary supplements they consume. supplements used to benefit the skin, hair and nails.
  • Action
    This is a Safety Alert, which highlights some recommendations: 1. TO THE DOCTOR: (i). Keep in mind that multivitamin compounds, including those used by pregnant women, as well as supplements for hair and nail growth and those that benefit the skin, may contain Biotin; (ii). Check with your patients if they consume diet products containing Biotin and advise them on the indicated products; Notify the clinical laboratory if the patient is taking Biotin supplement; (iii). If the laboratory results are not compatible with the patient 's clinic, investigate the patient' s use of Biotin, (iv). Notify ANVISA and the product registration holder of incorrect laboratory test results that have or have not caused an adverse event in the patient.//2. FOR ANALYSIS LABORATORIES: (i). Identify whether biotin-based assays are used and maintain contact with patients undergoing these assays, as well as with their physicians; (ii) .Question the patient - and record the answer in his / her form - if he / she consumes products that may contain Biotin or if they are treated with high doses of this vitamin of the B complex; (iii). In case of doubts about the interference of Biotin in tests in use in the laboratory, consult the company that holds your registry; (iv). Notify ANVISA and the product registration holder of incorrect lab results (falsely high or falsely low) that have or have not caused an adverse event in the patient. FOR THE CONSUMER: (i). Tell your doctor if you are using vitamin supplements or are being treated on a high dose of Biotin; (ii). Remember that Biotin can be found in multivitamins (including prenatal) and supplements for skin and hair and nail growth; (iii). If you have undergone a laboratory examination and suspected biotin interference in your result, please notify ANVISA and the product registration holder.

Device

Laboratory tests using biotin technology assay methodologies to promote binding with specific pro...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA