Events

Safety Alert for RAPIDPoint 500 SYSTEM, Hazard Class I, Registration: 10345161877, Serial numbers: 33897; 34218; 34225; 34227; 34497; 34502; 34515; 34516; 34607; 34608; 34611; 34974; 34975; 34977; 34982; 34986; 34990; 35096; 35097; 35098; 35664; 35666; 35667; 35669; 35671; 35672; 35680; 35724; 35726; 35728; 35729; 35979; 36044./////. RAPIDLab 1200 SYSTEMS, Model: RAPIDLab 1265, Registration: 10345160455, Serial numbers: SEE ANNEX.

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

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
    1518
  • Date
    2015-01-29
  • 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
    According to data from the manufacturer the health risk related to this issue is limited to the delay in the detection of hyperbilirubenia, while the result is confirmed by biochemical tests if the value found is lower than expected. If you get a result that is greater than expected, phototherapy would already be started and any change in therapy would require confirmation by laboratory biochemical tests.
  • Reason
    Siemens healthcare diagnostics reported a change in the measurement of the neonatal bilirubin parameter (nbili), which may have a variable increase when the concentration of nbili is> 12mg / dl (205 μmol / l) and the thb concentration exceeds the reportable range greater than 25 g / dl (15.5 mmol / l). when this occurs, the analyzer may report results of nbili greater or less than expected.
  • Action
    Siemens advises customers to perform the procedures described below, and to wait for the company to be scheduled for correction and to file the letter with the laboratory files: • If your analyzer reports "----- ↑" in the result of tHb, and the nBili result is reported, do not release the nBili result reported by the analyzer. • Please review the letter with the Clinical Director of your Laboratory. • Fill in and return the Effective Verification Form attached to the letter to the customer within 7 days. /// (SEE LETTER TO THE CUSTOMER IN ANNEX)

Device

RAPIDPoint 500 SYSTEM, Hazard Class I, Registration: 10345161877, Serial numbers: 33897; 34218; 3...

Manufacturer

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