BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1328877 · Received February 27, 2009

    Report

    Report Number
    2027969-2009-00068
    Event Type
    Injury
    Date Received
    February 27, 2009
    Date of Event
    February 5, 2009
    Report Date
    February 27, 2009
    Manufacturer
    BIOSITE
    Product Code
    JPA
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS REPORTABLE BECAUSE A RECURRENCE MAY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. DISCREPANT RESULTS (PRECISION) COMPARISON OF INRATIO TEST RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: FOR TEST 1, THE REPORTED INR VALUES FROM THE COMPLAINT WAS >7.5. SUCH VALUE ARE ABOVE 5.0 AND NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. FROM TEST 2 TO 4, THE PERCENTAGE OF CV IS 13% WHICH IS LESS THAN 20%. THE PRECISION DATA PASSES THE CRITERIA FOR PRECISION. THE DATA REPORTED IS CONSIDERED PRECISE, AND THEREFORE, NO FURTHER TESTING BEYOND INVESTIGATION IS REQUIRED AT THIS TIME. PROPER TECHNIQUE TIPS PROVIDED BY MANUFACTURER. DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CALLER CONTACTED MANUFACTURER REGARDING DISCREPANT RESULTS OF VARIOUS RANGES RECORDED OBTAINED. INRATIO INRS OF PATIENT IN QUESTION ARE: 2009: >7.5 ERROR AND REPEAT WAS THE SAME. COUMADIN WAS HELD. THE FOLLOWING THREE DAYS: 3.6, 3.4, 4.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE 0100004

    Patients

    Seq Age Sex Outcome Treatment
    1 NI