Events

Device Recall Guardian RealTime Monitor 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
    71816
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2442-2015
  • 사례 시작날짜
    2015-07-22
  • 사례 출판 날짜
    2015-08-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139146
  • 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
    Sensor, glucose, invasive - Product Code MDS
  • 원인
    Medtronic minimed is recalling the guardian real-time continuous glucose monitoring system because it has a language translation error that impacts the finnish language. specifically, the monitor has a finnish translation error in predictive alerts setting: the on-screen finnish translation for low/high is reversed as high/low.
  • 조치
    A Urgent Medical Device recall letter was sent to customers on 7/22/15 to inform them that the Guardian Real-Time Continuous Glucose Monitoring System System has a language translation error that impacts the Finnish language. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns are instructed to contact Nordic Support Line 0-800-164-064.

Device

Device Recall Guardian RealTime Monitor
  • 모델명 / 제조번호(시리얼번호)
    GLU100968U GLU102603U GLU102604U GLU102606U GLU102611U GLU102633U GLU105144U GLU104941U GLU105216U GLU113873U KIT207482U KIT207495U KIT209292U KIT209308U KIT209282U KIT209297U KIT207481U KIT207491U KIT207494U KIT209284U KIT227732U KIT227735U KIT227740U KIT227746U KIT229227U KIT229224U KIT237462U KIT207486U KIT241304U KIT241308U KIT241292U KIT242887U KIT210467U KIT210465U KIT242885U KIT242888U KIT242890U KIT242893U KIT210485U KIT254775U KIT254779U KIT247924U KIT258441U KIT249491U KIT263472U KIT226461U KIT258451U KIT249497U KIT249498U KIT259531U KIT265811U KIT258445U KIT267592U KIT267602U KIT255788U KIT267584U KIT267573U KIT267597U KIT267576U KIT267599U KIT265806U KIT259534U KIT265804U KIT270748U KIT270754U KIT270759U KIT269538U KIT269540U KIT269535U KIT270765U KIT270767U KIT270769U KIT270773U KIT273802U KIT280803U KIT280805U KIT280806U KIT280807U KIT280808U KIT280816U KIT286957U KIT280818U KIT280819U KIT280804U KIT300938U KIT300907U KIT300911U KIT300929U KIT300967U KIT300970U GLU118597U KIT309260U KIT309261U KIT309259U KIT309270U KIT309282U KIT311088U KIT311073U KIT311064U KIT311092U KIT311065U GLU118509U KIT312757U KIT312761U KIT312763U KIT312766U KIT312769U KIT312774U KIT312781U KIT321125U KIT323925U KIT323927U KIT321128U KIT323921U KIT329501U KIT328377U KIT328379U KIT328381U KIT329497U KIT322588U KIT323920U KIT326942U KIT326943U KIT326946U KIT326949U KIT326950U KIT311082U KIT311067U KIT311081U KIT326951U KIT326952U KIT331688U KIT331679U KIT307592U KIT352678U KIT352679U KIT352681U KIT352682U KIT352686U KIT352688U KIT352694U KIT346026U KIT346034U KIT346046U KIT346048U KIT346054U KIT346055U KIT352685U KIT352693U KIT346012U KIT331691U KIT354998U KIT364697U KIT364723U KIT364769U KIT364801U KIT364703U KIT364706U KIT364775U KIT364778U KIT364779U KIT364781U KIT364790U KIT364793U KIT364799U KIT364709U KIT364719U KIT354993U KIT364711U KIT369439U KIT369438U KIT369442U GLU120263U KIT367592U GLU118506U KIT355018U KIT355019U KIT355022U GLU121754U KIT369467U KIT369449U KIT367590U KIT369452U KIT369456U KIT375329U KIT375325U KIT373272U KIT373290U KIT355014U KIT375324U KIT375328U KIT367608U KIT373294U KIT373295U KIT311093U KIT364715U KIT355017U KIT364707U KIT423531U KIT373292U KIT423522U KIT426662U KIT426673U KIT423499U KIT426632U KIT423525U KIT434576U KIT433527U KIT433525U KIT434587U KIT434586U KIT434591U KIT434597U KIT440490U KIT440501U KIT436247U KIT446569U KIT434603U KIT442371U KIT442376U KIT445016U KIT440488U KIT445039U GLU124286U KIT442329U KIT426641U KIT426661U KIT446576U KIT442379U KIT442398U KIT355016U KIT445048U KIT443807U KIT443764U KIT426642U KIT442336U KIT445047U KIT445019U KIT442332U KIT442343U KIT442353U KIT442365U KIT443752U KIT436245U KIT442381U KIT442408U KIT445029U KIT440494U KIT440497U KIT440489U KIT440499U KIT440506U KIT440492U KIT440505U
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Distributed in Finland.
  • 제품 설명
    Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.
  • 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