Events

Medtronic MiniMed(TM) Quickset(TM) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic 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
    78125
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0107-2018
  • 사례 시작날짜
    2017-09-10
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158697
  • 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
    Set, administration, intravascular - Product Code FPA
  • 원인
    Medtronic minimed(tm) infusion sets have the potential for over-delivery of insulin.
  • 조치
    The firm initiated its recall on 09/11/2017 by issuing a public notice, following with letters and emails. The firm also employed the use of Facebook and Twitter as well as posting on its website. The recall notice directs the customer to visit https://checklots.medtronicdiabetes.com for information on the lot numbers. Persons with additional questions may call Medtronic at 1.888.204.7616.

Device

Medtronic MiniMed(TM) Quickset(TM)
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 5179671 5179672 5179675 5179676 5179678 5179680 5174468 5174471 5185640 5185642 5185643 5185645 5185647 5185648 5185650 5176067 5176070 5176073 5176074 5176079 5176082 5176085 5185660 5185663 5185666 5185669 5185672 5185673 5176224 5176050 5176052 5176054 5176056 5189836 5189838 5189839 5173751 5173752 5189378 5189379 5189380 5174455 5174457 5174459 5174461 5189358 5189359 5189362 5189364 5189366 5185736 5174481 5174483 5174485 5174487 5189386 5189388 5189390 5189392 5189394 5189395 5179685 5179686 5179687 5179688 5179689 5170715 5170823 5170825 5170827 5173463 5174300 5173470 5173471 5173472 5173473 5173474 5173475 5173476 5173477 5170133 5170134 5170135 5179710 5179711 5179712 5179713 5179714 5179715 5179716 5179717 5179718 5179719 5179720 5179721 5179722 5179723 5179724 5179725 5179726 5179727 5179728 5170153 5170154 5170155 5179690 5179691 5179692 5179693 5179694 5179695 5179696 5179697 5179698 5179699 5179700 5179701 5179702 5179703 5179704 5179705 5175939 5175940 5176014 5176015 5176016 5176017 5176018 5176019 5176020 5176021 5176022 5176023 5176024 5176025 5180499 5180500 5180501 5180502 5180503 5180504 5180505 5180506 5180507 5180508 5180509 5180510 5180511 5180512 5180513 5180514 5180515 5180516 5180517 5180518 5185600 5185601 5185602 5185603 5185604 5185605 5185606 5185607 5185608 5185609 5185610 5185611 5185612 5185613 5185614 5185615 5185616 5185617 5185618 5185619 5188097 5188098 5188099 5188100 5188101 5188102 5188103 5188104 5188105 5188106 5188107 5188108 5188109 5188110 5188111 5188112 5188113 5188114 5188115 5189846 5189847 5189852 5189853 5171629 5171630 5171631 5171632 5171633 5171634 5171635 5171636 5171637 5171638 5171639 5171640 5171641 5171642 5171643 5171644 5171645 5171646 5171647 5171648 5176026 5176027 5176028 5176029 5176030 5176031 5176032 5176033 5176034 5176035 5176036 5176037 5176038 5176039 5176040 5176041 5176042 5176043 5176044 5176045 5179790 5179791 5179792 5179793 5179794 5179795 5179796 5179797 5179798 5179799 5179800 5179801 5179802 5179803 5179804 5179805 5179806 5179807 5179808 5179809 5179810 5179811 5179812 5179813 5179814 5179815 5179816 5179817 5179818 5179819 5180479 5180480 5180481 5180485 5179758 5179759 5179760 5179761 5179762 5179763 5179764 5179765 5179766 5179767 5179768 5179769 5179770 5179771 5179772 5179773 5179774 5179775 5179776 5179777 5179778 5179779 5179780 5179781 5179782 5179783 5179784 5179785 5179786 5179787 5179788 5179789 5185620 5185621 5185622 5185623 5185624 5185625 5185626 5185627 5185628 5185629 5185630 5185631 5185632 5185633 5185634 5185635 5185636 5185637 5185638 5185639 5189406 5189407 5189408 5189409 5189410 5189411 5189412 5189413 5189414 5189415 5189416 5189417 5189418 5189419 5189420 5189421 5189422 5189423 5189424 5189425 5189426 5189427 5189428 5189429 5189430 5189431 5195705 5181716 5181718 5181720 5181722 5181723 5189446 5189449 5189451 5189452 5180519 5180522 5180525 5180528 5180530 5180531 5180533 5170898 5170901 5170904 5182140 5182143 5182145 5182146 5182149 5170619 5170622 5182158 5182161 5182163 5182164 5182166 5182167 5165412 5182139 5188235 5173794 5173795 5173796 5173797 5173798 5173799 5173800 5173801 5173802 5173803 5173804 5173805 5173806 5173807 5173808 5173809 5173810 5173811 5173812 5173813 5173814 5173815 5173816 5173817 5173818 5173819 5173820 5173821 5173822 5173823 5173824 5173825 5173826 5173827 5173828 5173829 5173830 5173831 5173832 5180451 5180452 5180453 5180454 5180455 5180456 5180457 5180458 5180459 5180460 5180461 5180462 5180463 5180464 5180465 5180466 5180467 5180468 5180469 5180470 5185480 5185481 5170855 5170856 5170857 5170858 5173753 5173754 5173755 5173756 5173757 5173758 5173759 5173760 5173761 5173762 5173763 5173764 5173765 5173766 5173767 5173768 5173769 5173770 5173771 5173772 5173773 5173774 5173775 5173776 5173777 5173778 5173779 5173780 5173781 5173782 5173783 5173784 5173785 5173786 5173787 5173788 5173789 5175967 5175968 5175969 5175970 5175971 5175972 5175973 5175974 5175975 5175976 5175977 5175978 5175979 5175980 5175981 5175982 5175983 5175984 5175985 5185590 5185591 5185592 5185593 5185594 5185595 5185596 5185597 5185598 5185599 5190564 5190565 5175947 5175948 5175950 5175951 5189466
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide
  • 제품 설명
    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • 제조사 주소
    Medtronic 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