Events

Animas Vibe Insulin Infusion Pump 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
    69299
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1034-2015
  • 사례 시작날짜
    2011-09-06
  • 사례 출판 날짜
    2015-01-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130189
  • 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, to be used with invasive glucose sensor - Product Code OYC
  • 원인
    Calibration factors in the pump overwritten during a programming step. the force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. field action initiated 8/29/2011.
  • 조치
    The field action was initiated on 8/29/2011 and comprised communication to patients and distributors using email, letters and verbal communication. In addition, notifications were sent to those Health Care Professionals who had patients that were affected by this field action. Health Authorities were notified in those countries where the pump had been distributed (France, Germany, Sweden and United Kingdom) or was in the hands of patients. Replacement product was provided to distributors and end users who were identified as having affected product.

Device

Animas Vibe Insulin Infusion Pump
  • 모델명 / 제조번호(시리얼번호)
    Model Number(s):   100515-63 100510-63 100514-63 100512-63 100511-63 101200-03 100201-03 101202-03 101204-03 101205-03 101200-53 101202-53 101205-53 101200-02 101200-57 101201-57 101202-57 101204-57 101205-57 101200-63 101201-63 101202-63 101204-63 101205-63 101206-63
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.
  • 제품 설명
    Animas Vibe Insulin Infusion Pump. || This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation
  • 제조사 주소
    Animas Corporation, 200 Lawrence Dr, West Chester PA 19380-3428
  • Source
    USFDA