Events

SPOTCHEM ll Glucose, SPOTCHEM ll PANEL-1 and SPOTCHEM ll PANEL-V 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 ARKRAY Factory, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2016-01-28
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • 데이터 추가 비고
  • 원인
    It was found that a lower reading may be given for the glucose item when the blood glucose concentration of a sample exceeds approximately 350mg/dl. more specifically, when the blood glucose concentrafion exceeds the upper limit of the measurement range (450mg/dl), the message ”over”, indicating that the reading is outside the measurement range, was not displayed and readings of approximately 300~400mgldl may be given. in addition, when within the measurement range, for high glucose concentrations (approximately 350~450mgldl), there is a possibility that the reading may be around -20% of the known concentration. .

Device

SPOTCHEM ll Glucose, SPOTCHEM ll PANEL-1 and SPOTCHEM ll PANEL-V
  • 모델명 / 제조번호(시리얼번호)
    SPOTCHEM ll Glucose (IVD) (Code77160) Lot: EA5H87,EA5G86,EA5F84,EA5E83,EA5D82,EA5B80,EA5A79 SPOTCHEM ll PANEL-1 (IVD) (Code 77184) Lot : QCSJ49,QC5H48,QC5G47,QC5F46,QC5E45,QC5D44,QC5C43,QCSB42,QC5A41 SPOTCHEM ll PANEL-V (IVD) (Code 77189) Lot : PL5J03,PL5H02,PL5601,PL5F99,PL5E98,PL5D97,PL5C95,PL5894,PL5A93
  • Manufacturer
    ARKRAY Factory, Inc.

Manufacturer

ARKRAY Factory, Inc.