Events

Device Recall AccuChek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Roche 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
    76870
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1899-2017
  • 사례 시작날짜
    2017-03-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-01-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154435
  • 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
    Calculator, drug dose - Product Code NDC
  • 원인
    A program error (bug) in the bolus advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.
  • 조치
    Roche Diabetes Care, Inc. discovered a software issue in the Accu-Chek Connect app versions 2.0.0, 2.0.1, and 2.1.0 that can result in incorrect bolus recommendations. This software bug may result in errors in the active insulin calculation, creating the potential for a false high insulin bolus recommendation. An insulin bolus delivered based on potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Customer notices were distributed via mail on 03/30/2017, and the firm's website was also updated with recall information on that day. Customers were instructed to do the following: discontinue use of the bolus advisor feature in app versions 2.0.0, 2.0.1, and 2.1.0 (iOS & Android) until the corrected version is available. ¿ Provide patients with a copy of the enclosed Urgent Medical Device Correction 17-001. ¿ Complete the enclosed faxback form and fax it to Roche Diabetes Care, Inc., at 1-888-912-8456. ¿ If you have questions about the information in this notification, please contact Accu-Chek Customer Care by visiting accu-chek.com or by calling 1-800-688-4578. The corrected version of the app is expected to be available on or about April 13, 2017. New patients will be able to begin using the bolus advisor feature once the corrected version is available. Please advise your patients to visit accu-chek.com for updates regarding the availability of the corrected version of the app.

Device

Device Recall AccuChek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS a...
  • 모델명 / 제조번호(시리얼번호)
    Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DE, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV
  • 제품 설명
    Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android || Product Usage: || This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice.
  • Manufacturer
    Roche Diabetes Care, Inc.

Manufacturer

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