Events

Safety Alert for Commercial name: cobas b 123 <4> POC system Technical name: Analyzer For Ph and Gases Registration number ANVISA: 10287410948 Hazard class: I

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH.

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
    2156
  • Date
    2016-07-29
  • 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
    Actions to be taken by the client / user: (1) For the measurement of neonatal bilirubin from capillary tubes, the Clot Catcher should be used (03112012180 CLOT CATCHER (250 PCS)). And for the measurement of neonatal bilirubin from syringes, Clot Catcher PRO (clotting machine) should be used (05689856001 CLOT CATCHER PRO (100 PCS)). Use instruction version 10 of cobas b 123 already contains this recommendation (page 192). (2) Whenever measurement of neonatal bilirubin is performed, the tHb, O2Hb and MCHC parameters must be activated to be displayed on the measurement and print report. The tHb parameter must be active in the parameter panel. For the configuration of these parameters in the measurement report, refer to the "Results Display" section in the cobas b 123 Instruction for Use. For parameters activation in the parameter panel, refer to the section "Edit panel" in cobas's Instructions for Use b 123. In the measurement to generate MCHC results, the Hct parameter must be active in the parameter panel and the minimum sample volume must be 55 μL. The following two rules need to be applied for all measurements of neonatal bilirubin: A) If the tHb result is less than 4 g / dL or O2Hb is flagged with "sample error", the bilirubin value may be uncertain and the measurement should be redone with a fresh sample. B) If the MCHC measurement value is below the range given in Table 1 (see attached chart), the bilirubin value may be uncertain and the measurement should be redone with a fresh sample. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Reason
    Roche diagnostics gmbh, the legal manufacturer of the product involved in this notification, was aware of a problem that could lead in rare cases to erroneously low neonatal bilirubin results in the cobas b 123 system due to a delay in aspiration or incomplete aspiration of the sample to the bucket. the problem has been detected in a single client around the world. however, measures have been identified to reduce the occurrence of this potential problem and to ensure that measurements that may have generated erroneously low results are identified by customers. therefore, roche diagnóstica highlights the recommendations in the instructions for use to avoid, in rare cases, erroneously low neonatal bilirubin results in the cobas b 123 system. it also informs some temporary measures that can reduce the occurrence and ensure the detection of the problem until the final solution with software version 4.8 is available (availability forecast until december 2016).
  • Action
    Field Action Code SBN-CPS-2016-011 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

Commercial name: cobas b 123 <4> POC system Technical name: Analyzer For Ph and Gases Regis...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH