Events

ACCUCHEK 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Roche Diagnostics Operations, 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
    66605
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0385-2014
  • 사례 시작날짜
    2013-10-25
  • 사례 출판 날짜
    2013-11-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-01-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122710
  • 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
    System, test, blood glucose, over the counter - Product Code NBW
  • 원인
    There is a software synchronization issue with the accu-chek combo system. in rare cases, when the manual pump option is chosen on the accu-chek aviva combo meter, there is a possibility of receiving an incorrect bolus advice recommendation that may cause a temporary under delivery of insulin.
  • 조치
    The firm, Roche Diagnostics, sent an "URGENT MEDICAL DEVICE CORRECTION (UMDC)" letter dated October 29, 2013, via UPS to their consignees/customers. The letter described the product, problem and actions to be taken. The UMDC informed them of the software synchronization issue with the ACCU-CHEK Combo system that may cause a temporary under delivery of insulin. The customers were instructed to ensure they properly deliver the correction bolus when utilizing the Manual Pump option, as instructed in the Owners Booklet; and complete and return the Business Reply Card via fax to 1-877-282-0223. The Distributors were instructed to provide the UMDC to their direct customers. The HCPs were instructed to remind their patients to follow the instructions in the Accu-Chek Aviva Combo Meter Advanced Owners Booklet when utilizing Manual Pump option. Questions about the information contained in this UMDC are directed to ACCU-CHEK Pump Support, 24 hours a day, seven days a week at 1-800-688-4578.

Device

ACCUCHEK
  • 모델명 / 제조번호(시리얼번호)
    AccuChek Aviva Combo meter 05075645005 packaged in Accu-Chek Combo Kit mg US/English version, 05458544001 and Accu-Chek Combo Kit mg US/Spanish version, 05504686001.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ || The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • 제조사 주소
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • 제조사 모회사 (2017)
    Roche Holding AG
  • Source
    USFDA