Events

Device Recall Medtronic MiniMed Guardian 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
    68888
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2179-2014
  • 사례 시작날짜
    2014-07-21
  • 사례 출판 날짜
    2014-08-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128937
  • 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 monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected guardian monitors.
  • 조치
    Medical Device Recall letters dated July 21, 2014 andJuly 22, 2014 were sent to distributors, patients, and healthcare providers who purchased the Guardian REAL time monitors. The letters inform the customers of the problems identified and the actions to be taken. Distributors with questions are instructed to email rs.nrdlrinbox@medtronic.com. If healthcare professionals want to speak to Medtronic's medical officers then they are instructed to call (818) 576-4211, ext. 64511. Customers and healthcare professionals' patients are instructed to call Guardian Recall Hotline at (800) 646-4633, ext. 21090, 8am-6pm, CST.

Device

Device Recall Medtronic MiniMed Guardian Monitor
  • 모델명 / 제조번호(시리얼번호)
    CSS7100 and CSS7100K
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide:Distribution - US Nationwide and the countries of Croatia, Denmark, Finland, Germany, Netherlands, Norway, Sweden, Switzerland.
  • 제품 설명
    Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K || Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The information provided by these devices is intended for use in identifying potential episodes of high or low blood glucose. The information provided is not intended to be used directly for making therapy adjustment but rather to assist the user in determining that an additional fingerstick glucose measurement may be appropriate. Per the product labeling, all therapy adjustments should be based on fingerstick glucose measurements obtained using standard home glucose meters and not on the sensor glucose values provided by the Guardian REAL-Time monitor. The CSS7100 and CSS7100K monitors are identical expect for the fact that the CSS7100K monitor is a pediatric version that has a minimum programmable low alert setting of 90 mg/dL. The minimum programmable low glucose alert setting for the adult model (CSS7100) is 40 mg/dL.
  • 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