BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 775037 · Received August 14, 2006

    Report

    Report Number
    2954730-2006-00451
    Event Type
    Malfunction
    Date Received
    August 14, 2006
    Date of Event
    August 11, 2006
    Report Date
    August 14, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: (SEE SCANNED TABLE). PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE CONFIDENCE LIMITS OF TWO SETS OF DATA CANNOT BE DETERMINED. THE MEAN OF LAST SET OF DATA WERE >5.0 AND THE DIFFERENCE BETWEEN INR'S WAS >2.2. THE LAST SET OF DATA CONSIDERED INACCURATE. PRODUCTS WILL BE INVESTIGATED. PER INTERNAL PROCEDURE, IN-HOUSE RETAINS WERE TESTED USING THERAPEUTIC BLOOD FROM TWO DONORS. THE TEST RESULTS ARE AS FOLLOWS: (SEE SCANNED TABLE). BASED ON THE ABOVE TEST RESULTS, PER INTERNAL PROCEDURE, RETAIN STRIPS LOT 050678 MEETS THE CRITERIA FOR STRIP ACCURACY.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: (SEE SCANNED TABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 050678

    Patients

    Seq Age Sex Outcome Treatment
    1 *