Events

Device Recall AccuChek Inform II Blood Glucose Monitoring System. 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
    73253
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1172-2016
  • 사례 시작날짜
    2016-02-11
  • 사례 출판 날짜
    2016-03-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143632
  • 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
    Glucose dehydrogenase, glucose - Product Code LFR
  • 원인
    Accu-chek inform ii base unit might produce physical transmission errors in the form of data loss in the communication between the meter and the data management systems (dms). the issue can lead to the data loss or in the worst case to an erroneous assignment of the patient data (patient mismatch). the issue will only occur at sites using potct1-a communication via usb.
  • 조치
    Roche sent an URGENT MEDICAL DEVICE RECALL CORRECTION letter dated February 11, 2016, via UPS Ground (receipt required) to the consignee. The Consignee instructions were as follows: ¿ If currently using USB connectivity, follow the instructions outlined in this Urgent Medical Device Correction (UMDC) to determine if your base unit is affected by the issue. ¿ Until the new software is available, do not use USB connectivity if the base unit is affected by this issue; switch the connectivity method to Ethernet (TCP/IP) or Wi-Fi. Roche is not requesting return of affected product. Any returned product will be managed according to current procedures. Consignees with questions were instructed to contact the ACCU-CHEK Customer Care Service Center at 1-800-440-3638. For questions regarding this recall call 317-521-3911.

Device

Device Recall AccuChek Inform II Blood Glucose Monitoring System.
  • 모델명 / 제조번호(시리얼번호)
    Model/Catalog/Part Number: 05060290001; serial numbers: UU41000000 through UU41064963 and UU41064964 through UU41122741.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV.
  • 제품 설명
    Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System || Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling lancing devices.
  • 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