Clinical effects of calibration of CoaguChek XS PT ... | 合法醫療器材資訊網

由MTrautsch著作·2020·被引用1次—Basedontheexperiencesof1anticoagulationclinic,theCoaguChekXSPTTestStripcalibrationupdateandclassIrecalldidnotresultinameaningfulclinical ...

Objective: In January 2018, Roche Diagnostics calibrated CoaguChek XS PT Test Strips to the latest World Health Organization reference preparation. On September 12, 2018, Roche Diagnostics issued an urgent medical device correction statement warning of inaccurate international normalized ratio (INR) results greater than 4.5 and recommended additional confirmatory testing. Eight weeks later, on November 2, the U.S. Food and Drug Administration issued a class I recall of all affected lot numbers. The objective of this project was to determine the clinical effects of recalibration of CoaguChek on patients managed by the Anticoagulation Management Services (AMS).

Methods: Two retrospective chart reviews were conducted for patients seen by AMS from May 1 to September 11 and from September 12 to November 2, 2018. Data collected included date of INR, confirmatory testing (if applicable), reason for elevate...