Events

TRUEtrack and TRUEbalance Blood Glucose Monitoring Systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Nipro Australia 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-01079-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-10-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01079-1
  • 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
    As part of nipro diagnostics internal manufacturing process blood glucose meters are required to be reconfigured to meet country specific requirements. during the reconfiguration process, the unit of measure was set incorrectly on a small subset of truebalance and truetrack meters supplied in australia. specifically, a miscalibrated meter would use mg/dl instead of mmol/l, which is the standard unit used in australia.This recall was initiated by nipro australia prior to consulting with the tga.
  • 조치
    Nipro is advising users to check the serial number on the back of the meter to identify if their meter is affected. An alternative method for measuring blood glucose levels should be used if you have an affected meter. Affected meters can be returned to Nipro for a replacement unit. For more details, please see http://tga.gov.au/safety/alerts-device-nipro-glucose-meter-131031.htm .

Device

TRUEtrack and TRUEbalance Blood Glucose Monitoring Systems
  • 모델명 / 제조번호(시리얼번호)
    TRUEtrack and TRUEbalance Blood Glucose Monitoring Systems
  • Manufacturer
    Nipro Australia Pty Ltd

Manufacturer

Nipro Australia Pty Ltd