Events

Device Recall Medtronic MiniMed CareLink Pro 4.0 and Clinical 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic MiniMed Inc. 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
    70424
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1228-2015
  • 사례 시작날짜
    2014-11-10
  • 사례 출판 날짜
    2015-03-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-03-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133579
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Pump, infusion, insulin - Product Code LZG
  • 원인
    The firm is informing customers of a software error that might result in an inaccurate display of the temp basal time and duration in carelink clinical reports with data uploaded from the minimed 620g or 640g insulin pump.
  • 조치
    Medtronic MiniMed Inc. sent an Urgent Medical Device Correction letter in December 2014 to all affected customers. The firm states in their letter that patients can continue to use their MiniMed 620G and 640G insulin pump systems, and that there is no risk to patients caused by this issue. The firm instructs that when reviewing the CareLink Pro 4.0 or CareLink Clinicial reports from the MiniMed 620G and 640G insulin pumps not to use the Temp Basal graphic for clinical consideration. For questions regarding this recall call 818-567-4700.

Device

Device Recall Medtronic MiniMed CareLink Pro 4.0 and Clinical
  • 모델명 / 제조번호(시리얼번호)
    Medtronic MiniMed CareLink Pro 4.0 model MMT-7335WWP and Clinical model MMT-7334
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution to Japan only. CareLink Clinical is for clinical trials only (US and International)
  • 제품 설명
    CareLink Pro || Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory to: || - read and store history and settings data supported insulin pump models and supported blood glucose meters || - read and report user-programmable settings on supported pump models || - read device data from the CareLink Online system || - write new device data to the CareLink system || - generate reports from the patient records for use in managing the patient's therapy. || CareLink Clinical || Medtronic CareLink MMT-7334 is a network based software system residing on a computer server platform connected to the Internet. The system is designed to upload patient data from Medtronic MiniMed insulin pumps and supported third-party blood glucose meters to the MMT-7334 central database via a client PC (Personal Computer), which connects to supported devices. The data contained in MMT-7334 is accessible to users using a standard browser, i.e. Microsoft Internet Explorer, on a PC that is connected to the Internet. The user may view and print various reports generated from the device data uploaded to MMT-7334, plus additional information provided by the user. The product does not provide any medical advice to patients or physicians. This is currently only intended to be used in Clinical Trials. || Both products are CD ROMs.
  • Manufacturer
    Medtronic MiniMed Inc.

Manufacturer

Medtronic MiniMed Inc.
  • 제조사 주소
    Medtronic MiniMed Inc., 18000 Devonshire St, Northridge CA 91325-1219
  • 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
    USFDA