Events

One Touch Verio IQ Blood Glucose Monitoring System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2013-RN-00243-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-03-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00243-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    At extremely high blood glucose levels of 56.8 mmol/l and above, the onetouch verio iq meter will turn off instead of displaying the message "extreme high glucose above 33.3 mmol/l" as intended. on restart the meter will enter set up mode.
  • 조치
    Patients are advised to continue using their OneTouch Verio IQ meter until the replacement meter arrives. However, if the meter unexpectedly turns off and enters set-up mode after turning it back on, the patient should contact their Diabetes Nurse Educator or Health Professional as this may be an indication of extremely high blood glucose. Distributors and health services are being advised to immediately return all affected product.

Device

One Touch Verio IQ Blood Glucose Monitoring System
  • 모델명 / 제조번호(시리얼번호)
    One Touch Verio IQ Blood Glucose Monitoring SystemProduct Code: 02258801ARTG Number: 200176
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd