BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOCHRON MICROCOAGULATION TEST SYSTEM

    MDR report key: 772735 · Received October 18, 2006

    Report

    Report Number
    2248721-2006-00002
    Event Type
    Other
    Date Received
    October 18, 2006
    Date of Event
    September 12, 2006
    Report Date
    October 18, 2006
    Manufacturer
    INTERNATIONAL TECHNIDYNE INC. (ITC)
    Product Code
    JPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - REVIEW OF HISTORICAL COMPLAINT RECORDS FOR LIKE PRODUCT (J201) PERFORMED. ITC COMPLAINT NO MFG & USER REVIEWED EVENT CHRONOLOGY IN LIGHT OF PRODUCT LABELING LIMITATIONS RELATED TO CONDITIONS REQUIRING RETESTING AND / OR LABORATORY CONFIRMATION PRIOR TO DOSE REGIMEN MODIFICATION. CUSTOMER INDICATED NO PATIENT INJURY DUE TO EVENT. CUSTOMER INDICATED USE OF NON-ITC PUNCTURE DEVICE MAY ALSO BE CASUAL. CUSTOMER ADVISORY INITIATED EMPHASIZING CONDITIONS REQUIRING RETESTING AND/OR LABORATORY CONFIRMATION PRIOR TO DOSE REGIMEN MODIFICATION.

    Description of Event or Problem · 1

    PER VERBAL COMMUNICATION WITH FACILITY IN 2006 - DURING THE PROCESS OF SETTING AN APPROPRIATE INITIAL COUMADIN REGIMEN FOR A NEW PATIENT, 2-3 DAYS AFTER FIRST DOSE A 1.8 INR. PROTHROMBIN TEST (PT) REPORTED. COUMADIN ADMINISTRATION CONTINUED FOLLOWED BY ANOTHER PT RESULT OF 1.8 INR. COUMADIN DOSE ADMINISTRATION INCREASED, ANOTHER PT PERFORMED WITH RESULT OF 1.8 INR. FACILITY REQUESTED PATIENT HAVE REFERENCE LAB EVALUATION, PATIENT WAS INITIALLY NON- COMPLIANT WITH REQUEST. ULTIMATELY PATIENT SPECIMEN SENT TO REFERENCE LAB WITH RESULT OF 10.0 INR. FRESH FROZEN PLASMA ADMINISTERED TO PATIENT TO REVERSE COUMADIN EFFECT. NO PATIENT INJURY REPORTED DUE TO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON MICROCOAGULATION TEST SYSTEM HEMOCHRON PROTHROMBIN TEST (PT) ASSAY JPA INTERNATIONAL TECHNIDYNE INC. (ITC) N/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention COUMADIN (WARFARIN)