Events

cobas b 123 - neonatal bilirubin results with software sw4.7 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Roche Diagnostics 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
  • 날짜
    2016-11-29
  • 사례 출판 날짜
    2016-11-29
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161129.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: roche cobas b 123 - neonatal bilirubin results with software sw4.7 the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning cobas b 123 analyser manufactured by roche diagnostics. the affected device identifiers are 05122279001, 05122287001 and 05064694001 with software version sw v4.7. during an investigation of a complaint, the manufacturer has become aware of a software issue that may cause discrepancies between neonatal bilirubin results obtained with cobas b 123 <3> and <4> systems running software version sw v4.7 compared to systems running software version sw v4.5. the deviations are mainly apparent at high bilirubin values. for the overall population, it is not likely that the differences in results at the medical decision point would lead to an incorrect medical treatment. in the worst case, it is most likely that the sample will be re-tested respectively when a second blood sample will be drawn. for population most at risk (newborns under 28 days, particularly premature neonates borne 23+ week of gestation), a medical risk cannot be excluded. incorrect medical decisions, due to discrepant results of bilirubin, at the medical decision point according to the threshold tables and the treatment threshold graphs, provided with pediatric guidelines for management of hyperbilirubinemia, cannot be entirely ruled out. according to the manufacturer, the software issue has already been corrected in cobas b 123 poc system software version sw v4.8. if an immediate update to software version sw v4.8 is not possible, workaround instructions when using software version sw v4.7 are included in the field safety notice. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-21-25-november-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 november 2016.

Device

cobas b 123 - neonatal bilirubin results with software sw4.7
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Roche cobas b 123 - Neonatal Bilirubin Results with Software SW4.7
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics