Events

CareLink iPro Therapy Management Software MMT-7340 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia 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-2017-RN-01306-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01306-1
  • 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
    Medtronic have identified a time conversion error where data uploaded from the ipro2 recorder to the carelink ipro software using the new carelink ipro uploader feature may result in incorrect reports. this pertains only to reports generated between the 23rd and the 27th of september 2017 that used the new carelink ipro uploader feature. specifically, when data from the ipro2 recorder was uploaded using the new carelink ipro uploader feature, the glucose reading timestamps inadvertently defaulted to greenwich mean time (gmt) /coordinated universal time (utc). it has been determined that the difference in time zones could result in calculation and display errors on the reports. this could lead to potential differences or inaccuracies in the sensor tracings, which also affect the display of meals and activities and the resulting report.To date, there have been no reported events to medtronic regarding this issue.
  • 조치
    Medtronic has disabled the CareLink iPro Uploader feature for all users. CareLink iPro software has automatically reverted back to using the previous Java Applet function. Reports generated using the uploader feature may contain inaccurate data, and should not be used to make therapy adjustments. Medtronic advises repeating iPro2 evaluations for those studies uploaded between 24 September 2017 and 28 September 2017. Clinics do not need to uninstall the uploader feature as this has been disabled - Java Applet will upload recorder and meter data. For users with affected reports, Medtronic will be providing replacement sensors at no charge for each evaluation. There is no need to initiate a request for replacement sensors. Medtronic will notify CareLink iPro customers when the updated version of the Uploader is available.

Device

CareLink iPro Therapy Management Software MMT-7340
  • 모델명 / 제조번호(시리얼번호)
    CareLink iPro Therapy Management Software MMT-7340ARTG Number: 133091
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA