BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 795472 · Received December 8, 2006

    Report

    Report Number
    2954730-2006-00600
    Event Type
    Malfunction
    Date Received
    December 8, 2006
    Date of Event
    November 20, 2006
    Report Date
    December 5, 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: DATE:11/20, LAB:4.25, MEAN:5.125, CONFIDENCE LIMITS:CANNOT BE. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE CONFIDENCE LIMITS CANNOT BE DETERMINED. PRODUCTS WILL BE TESTED. IN-HOUSE RETAINS STRIPS LOT 060090 WERE TESTED USING THERAPEUTIC BLOOD FROM TWO DONORS. THE ACCEPTANCE CRITERIA IS AS FOLLOWS: IF THE MAL INR IS LESS THAN 2.0, THEN THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND THE MLA INR SHALL BE +/-0.5. IF THE MLA INR IS 2.0 - 4.5, THEN THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND THE MLA INR SHALL BE +/-1.0. THE TEST RESULTS OF RETAINS STRIPS LOT 060090 ON 7/14/06 ARE AS FOLLOWS: SEE SCANNED TABLE. BASED ON THE ABOVE TEST RESULTS, RETAINED LOT 060090 MEETS THE CRITERIA FOR STRIP ACCURACY.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 11/20, INRATIO:6.0, LAB:4.25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060090

    Patients

    Seq Age Sex Outcome Treatment
    1 *