BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 790757 · Received November 22, 2006

    Report

    Report Number
    2954730-2006-00585
    Event Type
    Malfunction
    Date Received
    November 22, 2006
    Date of Event
    November 3, 2006
    Report Date
    November 21, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TIME COMPLAINT WAS FILED: DATE 11/3; INRATIO 5.7, 6.8; LAB 4.7, 6.5; MEAN 5.2, 6.65. CONFIDENCE LIMITS CANNOT BE DETERMINED. PER INTERNAL PROCEDURE THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST SET OF DATA, THE CONFIDENCE LIMITS CANNOT BE DETERMINED. PRODUCTS WILL BE TESTED. FOR THE SECOND SET OF DATA, BOTH VALUES GREATER THAN 5.0, THE COMPARISON WAS NOT CONSIDERED INACCURATE. RESULTS OF TESTING PERFORMED ON 06/16/2006: RETAIN STRIPS LOT 050816 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. BASED ON THE TEST RESULTS, RETAIN STRIPS LOT 050816 MEETS THE CRITERIA FOR STRIP ACCURACY.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANTS RESULT COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE 11/3; INRATIO 5.7, 6.8; LAB 4.7, 6.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 050816

    Patients

    Seq Age Sex Outcome Treatment
    1 *