Events

Safety Alert for ADVIA CENTAUR TSH3-Ultra (TSH3-UL), Registration No. 10345161732 - Lots: 20614266; 20789266; 21060266; 22006266; 23675267; 23790267; 23971267; 24111267; 24509267; 25222267; 26377269; 26425269; 26725269; 27005269; 28270269; 29642270; 31163270; 32453271; 32953271; 3,420,527; 34987272; 35288272; . ADVIA CENTAUR VITAMIN D TOTAL (VIT D), Registration nº 10345161800 - Kit for 100 tests: Lots 20704023; 21215023; 21656023; 24042023; 25822024; 26961024; 28118025; 28507025; 31757026; 32787026 and Kit for 500 tests: Batches: 20640023; 21368023; 22792023; 26324024; 31817026; 34098026; 35698027; . ADVIA CENTAUR VITAMINA D TOTAL, Registration nº10345161889 - Lots: 33093052; 35197053; . ADVIA CENTAUR PROCALCITONIN (PCT), Record 10345161790 - Lots: 28917023; 31219024.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos Ltda..

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
    1389
  • Date
    2014-05-12
  • 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
    The company reports that, according to the manufacturer's research fluorescein has shown impact on TSH, Vitamin D and Procalcitonin results. This compound is used systemically to aid in angiographic imaging. Fluorescein angiography is a low-frequency procedure and is unlikely to occur coincidentally with testing for thyroid function, vitamin D, or clinical levels of procalcitonin. Based on risk analysis and mitigation, it was determined that the probability of occurrence is extremely unlikely, being P <0.000001 and lower severity in which it may lead to a temporary adverse consequence, which fits this situation as without health risk. The company further clarifies that falsely low values ​​of TSH3 Ultra can be found in patients who were injected with fluorescein sodium before the TSH test. These values ​​are important in the monitoring of thyroid cancer, since the doctor can determine that adequate thyroid suppression has been obtained. TSH levels are used to diagnose thyroid dysfunction in conjunction with fT4 and fT3, which would not coincide with the suppressed TSH result, leading to further investigation. False-high values ​​of Vitamin D will lead to further investigation, as it is unlikely to achieve such results without Vitamin D supplementation. False-reduced values ​​of Procalcitonin will lead to patient observation because, in case of suspected sepsis, the patient should be monitored clinically and biochemically and microbiologically tested.
  • Reason
    Siemens healthcare diagnostics has confirmed that samples containing fluorescein may show interference with the tsh3 ultra, vitamin d and advia centaur brahms procalcitonin tests on advia centaur® systems. evidence suggests that patients undergoing angiography with fluorescein dye contrast can retain small amounts of the same in the body for up to 48 to 72 hours post-treatment. in the case of patients with renal failure, the retention of fluorescein may be greater. fluorescein-containing specimens may result in: - lower values ​​when tested with the advia centaur tsh3 ultra test, which may be less than <0.01 miu / l - lower values ​​when tested with the advia centaur brahms procalcitonin test, which may be less than <0.02 ng / ml. - high values ​​when tested with the advia centaur vitamin d test, which may be greater than> 150 ng / ml (> 375 nmol / l). samples from the above tests should be re-subjected to post-clearance of fluorescein to ensure that there is no interference in the test results.
  • Action
    Clients were instructed not to use the blood test collected from a patient who underwent fluorescein dye contrast angiography without allowing the fluorescein to be counted and to keep the letter with the laboratory records. The use of the tests can be continued on any sample that does not contain fluorescein.

Device

ADVIA CENTAUR TSH3-Ultra (TSH3-UL), Registration No. 10345161732 - Lots: 20614266; 20789266; 2106...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA