Events

Safety Alert for cobas b 123 Sensor Cartridge BG / ISE / GLU / LAC, an integral part of the COBAS B 123 POC System equipment (Record 10287410948) - Affected Lots Distributed in Brazil: 21552191/21552491/21552591/21552692

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
    1689
  • Date
    2015-09-18
  • 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
    Due to a potential risk of PCO2 interference in sodium (Na +) results in the specific batches of sensors, overestimated Na + results can be generated. The interference of PCO2 in Na + in patient samples causes potential risks only for patients with PCO2 increase, or with PCO2 at the upper end of the normal range. To date, there are no known cases where this issue caused any serious adverse events for patients.
  • Reason
    Roche diagnostics gmbh, the legal manufacturer of the products involved in this notification, during internal investigations, identified that specific batches of sensors called cobas b 123 sensor cartridge bg / ise / glu / lac, an integral part of the cobas b 123 system, exhibited pco2 interference in (na +) results in whole blood samples. the positive deviation in the sodium results increases with the pco2 values ​​(partial pressure of carbon dioxide) of the samples.
  • Action
    The company recommends that - For measurement of the Na + parameter, unaffected batches of cobas b 123 Sensor Cartridges BG / ISE / GLU / LAC should be used. The affected batches are listed in Table 1 of the notification letter; all other batches, including subsequent batches, are not affected by this problem. - Whenever one of the affected batches listed in Table 1 of the Notification is used or is currently in use, one of the cobas b 123 Sensor Cartridges BG / ISE / GLU / LAC should be deactivated in order to avoid any risk of release too high sodium. For details on disabling Na +, see Appendix 1 of the Notification. -Alternatively, affected Cartridge sensors currently in use in the analyzer may be replaced by Non-Affected Batch Sensors. -The cobas b 123 Sensor Cartridges BG / ISE / GLU / LAC of affected batches not yet used can be discarded locally. - The replacement of affected lots may be requested from Roche Diagnóstica Brasil Ltda.

Device

cobas b 123 Sensor Cartridge BG / ISE / GLU / LAC, an integral part of the COBAS B 123 POC System...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH