BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 798146 · Received December 15, 2006

    Report

    Report Number
    2954730-2006-00618
    Event Type
    Malfunction
    Date Received
    December 15, 2006
    Date of Event
    December 5, 2006
    Report Date
    December 15, 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 11/30, INRATIO 6.9, LAB 2.48, MEAN 4.69, CONFIDENCE LIMITS 2.6-6.9. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE LAB VALUES WAS OUTSIDE THE CONFIDENCE LIMITS FOR INR TESTING. PRODUCTS WILL BE TESTED. IN-HOUSE RETAINS STRIPS LOT 060452 WERE TESTED USING THERAPEUTIC BLOOD FROM TWO DONORS. THE ACCEPTANCE CRITERIA IS AS FOLLOWS: IF THE MLA 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 LOTS 060452 DONE ON 12/07/2006 ARE AS FOLLOWS: SEE SCANNED TABLE. BASED ON THE ABOVE TEST RESULTS, RETAINED LOT 060452 MEETS THE CRITERIA FOR STRIP ACCURACY.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARE WITH THE LAB. RESULTS AS FOLLOWS: DATE 11/30, INRATIO 6.9, LAB 2.48.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060452

    Patients

    Seq Age Sex Outcome Treatment
    1