Events

Device Recall AccuChek Connect Diabetes Management App 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
    79001
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0625-2018
  • 사례 시작날짜
    2017-06-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161061
  • 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
    Certain ios and android app versions contain a program error (bug) in the bolus advisor feature. due to a software bug, when the os region of the phone setting is changed, the unit of measure within the app may unexpectedly change. this creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.
  • 조치
    On 06/13/2017, Roche Diabetes Care, Inc. made the Urgent Medical Device Correction notice available to their customers through the Accu-Chek.com website and through the Accu-Chek Connect microsite. Patients are instructed to: Update to version 2.1.1 of the Accu-Chek Connect app Clear all data from the Accu-Chek blood glucose meter following the steps below, before pairing with the Accu-Chek Connect app for the first time. This clearing of the records in the memory can be accomplished on the PC or Mac by using Accu-Chek Connect Device Link. A micro-USB cable and an Accu-Chek Connect Online account are required. Also ensure that the date and time are set correctly on the blood glucose meter before pairing with the app. Failure to follow these directions might impact first time use of the apps Bolus Advisor feature. ¿ Steps to clear data from Accu-Chek meter in Connect Online: 1. Create or login to your Connect Online account on your PC or Mac. 2. Download Accu-Chek Device Link 3. Right-click on Device Link icon in system tray or dock. 4. Select Settings >Prompt after every successful upload under the Delete Patient Results from Device heading. 5. Connect your meter via micro-USB cable. 6. Follow the onscreen instructions to upload your data and clear your meter. If you use the apps Bolus Advisor feature, please carefully review and manage your active insulin and insulin bolus amounts for the first 8 hours after initial installation of the app and pairing your meter. This ensures the software will establish an accurate history for use in future bolus recommendations. They are advised to contact Accu-Chek Customer Care at 1-800-688-4578 if there are additional questions.

Device

Device Recall AccuChek Connect Diabetes Management App
  • 모델명 / 제조번호(시리얼번호)
    Software Versions: 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, and 2.1.0
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide
  • 제품 설명
    Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
  • 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