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
    77635
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0197-2018
  • 사례 시작날짜
    2017-06-08
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156980
  • 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. after pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown timer is not displayed and correction bolus advice is not available for the most recent, valid glucose reading. this same blood glucose value may become available for bolus advice calculation at a later time (countdown timer is displayed).
  • 조치
    Roche Diabetes Care sent an Urgent Medical Device Correction letter dated June 12, 2017, to all affected customers. The potential for inaccurate bolus insulin advice can only be encountered if the blood glucose meter has displayed a single E-10 Time/Date error message and the meter had blood glucose records in My Diary and then the meter is pared for the first time with the Accu-Chek Connect App. A customer encountering this issue may find the app does not display the bolus advice option and, consequently, correction bolus advice is not available on the most recent, valid glucose reading. This blood glucose value that could not be used initially may become available for bolus advice calculation at a later time. If the app provides the bolus advice option more than 15 minutes after you tested, it could lead to an incorrect bolus insulin recommendation that should not be used. To completely avoid the possibility of this issue occurring, it is important for Accu-Chek Connect app users to follow the following directions when pairing a meter with the app for the first time: Clear all data from your 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 your 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 your 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 your 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 y

Device

Device Recall AccuChek Connect Diabetes Management App
  • 모델명 / 제조번호(시리얼번호)
    Software Versions 1.0.5, 1.0.15, 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, 2.1.0, and 2.1.1 for iOS and Android.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) and Canada
  • 제품 설명
    Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 || The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data
  • 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