Events

SYMPHONY GLUCOSE MANAGEMENT SYSTEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Animas Corporation 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
    49476
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0290-2009
  • 사례 시작날짜
    2008-08-04
  • 사례 출판 날짜
    2008-11-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-02-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73523
  • 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
    Insulin infusion pump - Product Code LZG
  • 원인
    Unintentional rebooting: pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. the failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.
  • 조치
    The recalling firm issued a notification letter to the patients with insulin pumps on 8/5/08 to inform them of the problem and that they needed to replace the battery. The recalling firm contacted OneTouch Ping users by telephone on 8/5/08 for this issue and another issue. The recalling firm issued letters to distributors informing them of the problem and notified customers to replace the batteries. In addition, a letter was issued to physicians to alert them of the situation with regard to current patients. Consumers can contact 1-800-423-4087 for additional information or questions.

Device

SYMPHONY GLUCOSE MANAGEMENT SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Part Number: 100-158-01. All units (no serial numbers).
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand, Spain, Switzerland, and Sweden.
  • 제품 설명
    Battery Caps used with insulin pumps and glucose monitoring systems. || The pump is used to help maintain blood glucose targets.
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation
  • 제조사 주소
    Animas Corporation, 200 Lawrence Dr, West Chester PA 19380
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA