Events

Freestyle Navigator Continuous Glucose Monitor System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Diabetes Care, 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
    52635
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1454-2010
  • 사례 시작날짜
    2009-04-14
  • 사례 출판 날짜
    2010-04-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-03-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90252
  • 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
    Continuous glucose monitor - Product Code MDS
  • 원인
    Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.
  • 조치
    Notification letters were issued to FreeStyle Navigator customers via certified mail and notification was posted on the Abbott Diabetes Care's Website. Customers were notified of the potential issue and actions to take: 1) if moisture is observed in the FreeStyle Navigator transmitter now or at any time, discontinue use of the transmitter and call Abbott Diabetes Care Customer Care at 1-800-418-6427 and 2) if a loss of connection is encountered or if your results are not reliable or are inconsistent with how you feel, consult your User's Guide for troubleshooting guidelines. If the issue is not resolved, call Abbott Diabetes Care Customer Care at 1-800-418-6421. For outside-of-US accounts, the firm's regional offices will distribute notices to identified customers in the appropriate language.

Device

Freestyle Navigator Continuous Glucose Monitor System
  • 모델명 / 제조번호(시리얼번호)
    Abbott Item # 70966-04 with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M1658 or 01M1968 or 01M2548 or 01M2828. Kit Serial numbers beginning with: BAAH 186 or BAAH 207 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 261 or BAAH 275 or BAAH 290 or BAAH 299 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH139 or AAAH 158 or AAAH 195 or AAAH 212 or AAAH 221 or AAAH 239 or AAAH 268 or AAAH 296 and followed by a five (5) digit number.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.
  • 제품 설명
    Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL (EMEA) SV. Abbott Item Number 70966-04, distributed by Abbott Diabetes Care Inc, Alameda, CA. || Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
  • Manufacturer
    Abbott Diabetes Care, Inc.

Manufacturer

Abbott Diabetes Care, Inc.
  • 제조사 주소
    Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
  • Source
    USFDA