Events

Sunquest Laboratory 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sunquest Information Systems, 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
    48174
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0207-2009
  • 사례 시작날짜
    2008-04-17
  • 사례 출판 날짜
    2008-10-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70931
  • 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/data processing module - Product Code JQP
  • 원인
    Sunquest has identified a problem with igo interfaces when performing an online file cleanup (ofc) that can lead to the test results of one patient filing to another patient when the order codes are the same. performing an ofc prior to all results being assigned an accession number may cause the patient results to remain in a temporary file where they can be incorrectly associated to the wrong pat.
  • 조치
    Customers were sent a preliminary notice on 4/17/2008 followed by customer notice PSN-08-04 on 05/07/2008 via email. The notice advises that this notice is follow-up to the Preliminary notice distributed on 4/17/08 and applies to all clients who have an Instrument Generated Order (IGO) interface. Sunquest has identified a problem with IGO interfaces when performing an Online File Cleanup (OFC) that can lead to the test results of one patient filing to another patient when the order codes are the same. Performing an OFC prior to all results being assigned an accession number may cause the patient results to remain in a temporary file where they can be incorrectly associated to the wrong patient. When this occurs, Sunquest generated reports and inquiry contains the incorrect results. The letter provides the various steps that cause the issue to occur. Sites Potentially Affected by this Problem: Sunquest Laboratory using Instrument Generated Orders (IGO) Interface, Version 5.3 and later Action Sunquest Information Systems is taking to eliminate this Problem: Change Request 1-62VWLJ has been created to address this issue. This will be available as part of Sunquest Laboratory Instrument Build version 1.6.0023 and later. To request the software correction, customers can create a Service request via the Client support Webpage at www.sunquestinfo.com/supportweb. The notice also provides temporary procedural instructions: Effective immediately, do NOT perform Online File Cleanup (OFC) on any IGO instrument interface methods. -Manual OFC should not be performed using functions OFC, or Instrument Maintenance (IX or IXM), option 11 for IGO interfaces only. -If using function Instrument Maintenance (IX or IXM), option 1, 2, 2, Method, 2 (Automatic File Cleanup). This should be set to "N". Then stop and re-start the Instrument Results Processor. Note: Online file cleanup for non-IGO interfaces needs to be performed as usual. -Pending and Overdue Logs need to be monit

Device

Sunquest Laboratory
  • 모델명 / 제조번호(시리얼번호)
    Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Canada, Bermuda, Ireland, United Kingdom, United Arab Emirates, and Saudi Arabia.
  • 제품 설명
    Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3. || Sunquest Laboratory Information System is comprised of several modules which are involved in aspects such as blood banking, collection management, specimen tracking, and use with microbiology and molecular diagnostics. Key capabilities include: || 1) Autoverify results directly from analyzers and reference laboratories || 2) Track tubes and containers from order to final disposition || 3) Monitor key metrics such as turnaround time and utilization using management reports || 4) Produce pathology results with Structured Reports || 5) Suggest microbiology workups online according to defined SOPs and rules || 6) All data entered into the system is accessible through audit trails and Ad Hoc Report tools || 7) Any change to patient results (inquiry, reports) is logged and available for review
  • Manufacturer
    Sunquest Information Systems, Inc.

Manufacturer

Sunquest Information Systems, Inc.
  • 제조사 주소
    Sunquest Information Systems, Inc., 250 S Williams Blvd, Tucson AZ 85711-4472
  • 제조사 모회사 (2017)
    Roper Technologies Inc
  • Source
    USFDA