Events

Accu-Chek Inform II Base Unit and Handheld Base Unit, registry 10287410863, hazard class II, batches affected: 05802151 to 05205301 and 05809021 to 05205311. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1803
  • 날짜
    2015-01-22
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.
  • 원인
    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.
  • 조치
    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