Events

Safety Alert for Accu-Chek Inform II Base Unit and Handheld Base Unit, registry 10287410863, hazard class II, batches affected: 05802151 to 05205301 and 05809021 to 05205311.

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
    1803
  • Date
    2015-01-22
  • 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
    Complaints were reported to the Accu-Chek Inform II system when connected to the TI1000 cobas using the USB connectivity option. No case was reported for Ethernet or WLAN option. The affected BU / HBU are those with 3 years of use or the oldest ones. #### UPDATED ON 11/21/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Reason
    Potential risk of data loss during usb communication between the meter and the data management system. some accu-chek infrm ii base units (bu) and handheld base units (hbu) used in coaguchek professional meters and cobas h232 meters can produce physical transmission errors in the form of data loss in usb communication between the measured and the system of data management. this happens in rare cases of data transmission with pocti-a communication via a usb connection to a pc.
  • Action
    Customer communication and software update. Action code: SBN_RPD_2015_020. The company advises not to use the USB connectivity option without other precautions because the data loss produces invalid data. The manufacturer is developing a new version of the "Roche BU / HBU Control Panel" to improve flaws. The new version is planned for the first quarter of 2016. Workarounds to avoid the problem HW: change connectivity method or request from Roche a USB hub or active USB repeater to improve the signal.

Device

Accu-Chek Inform II Base Unit and Handheld Base Unit, registry 10287410863, hazard class II, batc...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH