Events

Safety Alert for Trade name: RAPIDPoint 400 Series; RAPIDPOINT 500 SYSTEM; RAPIDLAB 1200 SYSTEMS Technical Name: Biochemical Analyzer ANVISA Registration Number: 10345160460; 10345161877; 10345160455 Hazard Class: II Affected Model: RAPIDPoint 400; RAPIDPoint 400; RAPIDPOINT 500 SYSTEM; RAPIDLAB 1240; RAPIDLAB 1245; RAPIDLAB 1260; RAPIDLAB 1265 Batch / serial numbers affected: 9884; 9895; 11849; 11870; 12752; 12679; 12680; 12751; 9740; 36819; 34225; 35098; 35664; 35667; 34608; 34611; 35096; 35097; 35669; 35671; 35672; 35728; 35979; 36044; 36601; 36942; 36946; 37131; 37133; 37175; 37177; 37180; 37182; 37185; 37188; 37674; 37683; 37686; 37851; 37852; 37853; 34218; 34497; 34502; 34515; 37102; 34516; 34729; 36683; 36697; 37132; 37140; 37678; 37689; 37838; 37839.

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
    2097
  • Date
    2016-09-15
  • 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
    Siemens recommends that you do not configure the Analyzer with patient demographics (surname, first name) disabled and the quick sample identification option enabled. If sample IDs are scanned on the analysis screen, confirm that the patient ID is correct on the screen prior to sample analysis. Correct patient identification on the analysis screen if it is incorrect.
  • Reason
    Siemens healthcare diagnostics has determined that when all of the following steps occur there is a potential for the first name and / or surname of a patient to be printed with the identification and results data of a different patient, even if those fields have been disabled in the system . · 1. the blood gas analyzer is configured with the patient's personal data (surname, first name) disabled and the quick sample identification option (query host used to retrieve the patient's personal data fields in the data management system ) is enabled. · 2. a bar code with incorrect patient identification is scanned in the analysis screen before the sample is analyzed. · 3. incorrect identification of the patient and last name displayed on the analysis screen are not confirmed and corrected. · 4. the sample is analyzed and the correct identification of the patient is digitized or entered on the personal data screen by the operator. the patient identification the result of the analysis, however, are correct on the analyzer screen and the lis. only the printout may contain the incorrect first or last name, which should not have been pressed, since those fields were disabled in the configuration.
  • Action
    Field Action Code POC 16-021 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Letter to the Client.

Device

Trade name: RAPIDPoint 400 Series; RAPIDPOINT 500 SYSTEM; RAPIDLAB 1200 SYSTEMS Technical Name: B...

Manufacturer

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