BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON

    MDR report key: 1211759 · Received October 14, 2008

    Report

    Report Number
    1211759
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Report Date
    October 14, 2008
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION (ITC)
    Product Code
    GKP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ALL OF THE DATA WE ANALYZED HAD BEEN COLLECTED BY THE WARFARIN CLINICS FOR QA PURPOSES. WE OBTAINED IRB (INSTITUTIONAL REVIEW BOARD) APPROVAL FOR OUR ANALYSIS. WE CONDUCTED AN ANALYSIS OF 1,666 PAIRED INR SAMPLES (VENOUS SAMPLE AND POINT OF CARE DEVICE FROM THE SAME PATIENTS AT THE SAME TIME) OVER THE COURSE OF 2.5 YEARS. THE DEVICE DID NOT REPORT THE FOLLOWING INR VALUES: 2.1, 3.1, 3.8, 4.1, AND 4.4. INR VALUES OF 2.7 AND 3.5 OCCURRED ONCE. THERE IS NOT MUCH EVIDENCE THAT IT IS A SIMPLE ROUNDING ISSUE, SINCE VALUES ADJACENT TO THE MISSING VALUES DO NOT APPEAR TO BE SYSTEMATICALLY OVER-REPRESENTED. ADDITIONALLY, THE VALUE 2.5 (THE VALUE AT THE MIDDLE OF THE MOST COMMON TARGET INR RANGE) APPEARS TO BE OVER-REPRESENTED, ACCOUNTING FOR OVER 8% OF ALL VALUES REPORTED BY THE DEVICE. WE HAVE A GENERAL CONCERN WITH THE DISTRIBUTION OF VALUES FROM THE DEVICE COMPARED TO OUR ROUTINE LABORATORY. THE DEVICE TENDS TO INFLATE INR VALUES COMPARED WITH THE LAB, ESPECIALLY AT THE LOW END OF THE INR SCALE. THIS COULD LEAD CLINICIANS TO BELIEVE THE PATIENT IS WITHIN THE TARGET INR RANGE WHEN THE LABORATORY INR WOULD INDICATE THE SAME PATIENT IS AT SIGNIFICANTLY INCREASED RISK FOR A THROMBOEMBOLIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON ANALYZER, COAGULATION, WHOLE BLOOD GKP INTERNATIONAL TECHNIDYNE CORPORATION (ITC) HEMOCHRON SIGNATURE JUNIOR PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 *