Ann Lab Med.  2023 Sep;43(5):515-519. 10.3343/alm.2023.43.5.515.

Real-World Evidence of Point-of-Care Glucometers: Enhanced Passive Surveillance and Adverse Event Reporting Status in Korea and the United States

Affiliations
  • 1Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
  • 2Soonchunhyang Medical Devices Clinical Research Center, Soonchunhyang University, Asan, Korea
  • 3Division of Nephrology, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea


Figure

  • Fig. 1 Enhanced passive surveillance applied to POC glucometer adverse event reporting; (A) Overview and (B) IMDRF code conversion of reported adverse events using checklist. Abbreviations: POC, point-of-care; QC, quality control; IMDRF, International Medical Device Regulator Forum.


Cited by  1 articles

Effectiveness of Unified Computerized Reporting of Point-of-Care Glucose Meter Test
Sooin Choi, Dughyun Choi, Soo Jeong Choi, Jin Kuk Kim, You Kyoung Lee, Yong-Wha Lee
Ann Lab Med. 2024;44(1):103-106.    doi: 10.3343/alm.2024.44.1.103.


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