BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 727454 · Received June 9, 2006

    Report

    Report Number
    2954730-2006-00346
    Event Type
    Malfunction
    Date Received
    June 9, 2006
    Date of Event
    April 6, 2006
    Report Date
    June 6, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Adverse Event
    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 - 04/06/06, PT#1 INRATIO=3.2, LAB=4.1, MEAN=3.65, CONFIDENCE LIMITS=2.2-5.3 DATE - 04/06/06, PT#2 INRATIO=4.8, LAB=5.4, MEAN=5.1, CONFIDENCE LIMITS CANNOT BE DETERMINED. PER INTERNAL PROCEDURE, TR 0150, THE CALCULATED MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE CONFIDENCE LIMITS OF PT#2 CANNOT BE DETERMINED. PRODUCTS WILL BE INVESTIGATED. PER PR 0103, IN-HOUSE RETAINS WERE TESTED USING THERAPEUTIC BLOOD FROM TWO DONORS. RETAIN STIPS TEST RESULTS: PT1, LOT 050664 =1.6, MLA INR = 1.47, DIFFERENCE (0.13), RESULT = PASS. PT1, LOT 050664 = 1.4, MLA INR = 1.47, DIFFERENCE 0.07, RESULT = PASS. PT1, LOT 050664 = 1.3, MLA INR = 1.47, DIFFERENCE 0.17 RESULT = PASS. PT2, LOT 050664 = 1.8, MLA INR = 1.71, DIFFERENCE (0.09), RESULT = PASS. PT2, LOT 050664 = 1.8, MLA INR = 1.71, DIFFERENCE (0.09), RESULT = PASS. PT2, LOT 050664 = 1.8, MLA INR = 1.71, DIFFERENCE (0.09), RESULT = PASS. A REVIEW OF BATCH RECORD LOT 050664 REVEALED NO MANUFACTURING ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE ALLEGED FAILURE. BASED ON THE ABOVE TEST RESULTS, LOT 050664 MEETS THE CRITERIA FOR STRIP ACCURACY.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 04/06/06 PT#1, INRATIO=3.2, LAB=4.1 DATE: 04/06/06 PT#2, INRATIO=4.8, LAB=5.4

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 050664

    Patients

    Seq Age Sex Outcome Treatment
    1 *