Events

Safety Alert for RAPIDPOINT 500 SYSTEM; Registration 10345161877, Serial Nos: 33897; 34218; 34225; 34227; 34516; 34502; 34515; 34497; 34607; 34608; 34611; 34975; 34990; 34982; 34977; 34974; 34986; 35098; 35097; 35096; 35664; 35671; 35669; 35667; 35672; 35666; 35729; 35680; 35728; 35726; 35724; 35979; 36044; 36601; 36604; 36603; 36693; 36697; 36683; 36639; 36819; 36814; 36813; 36818; 36812; 36811. (Annex 1)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A.; 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
    1676
  • Date
    2015-08-27
  • 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 record holder informs that duplicate or missing analyte as described above, poses no health risk. The results are readily available in the instrument for consultation and referral to the HIL. The health risk is limited to the extremely unlikely situation in which an analyte when being analyzed is switched between two patients. A transfected result of sodium, potassium, glucose, lactate, carboxyhemoglobin, methaemoglobin, or neonatal bilirubin may lead to a potential health risk when the actual value is critical. In all cases, the probability of occurrence is extremely unlikely due to the low frequency of occurrence of the software problem and correlation with the clinical presentation of the patient, history and laboratory tests.
  • Reason
    For users who have enabled dual-port lis transmission on the rapidpoint 500 system, siemens healthcare has identified that when both the serial and ethernet ports are configured to transmit data, the flow of data from a port can affect potentially the other's data stream.
  • Action
    The company advises that if the system is configured with Dual LIS transmission enabled, one of the ports (Serial or Ethernet) needs to be disabled. More information in the Letter to the Client (Annex 2).

Device

RAPIDPOINT 500 SYSTEM; Registration 10345161877, Serial Nos: 33897; 34218; 34225; 34227; 34516; 3...

Manufacturer

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