BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 968688 · Received October 6, 2006

    Report

    Report Number
    2954730-2006-00532
    Event Type
    Malfunction
    Date Received
    October 6, 2006
    Date of Event
    October 6, 2006
    Report Date
    October 6, 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 2006, INRATIO 5.6, 3.4, 4.5. LAB 4.5, 4.5, 4.5. MEAN 5.05, 3.95, 4.5, CONFIDENCE LIMITS CAN'T BE DETERMINED, 2.3-5.7, 2.5-6.5. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST SET OF DATA, THE CONFIDENCE LIMITS CAN'T BE DETERMINED. PRODUCTS WILL BE INVESTIGATED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060090: FIRST TEST INR = 5.6, SECOND TEST INR = 3.4, THIRD TEST INR = 4.5, MEAN = 4.5; SD = 1.1; %CV = 24%. THE %CV IS GREATER 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE 2006 INRATIO 5.6, 3.4, 4.5. LAB 4.5, 4.5, 4.5. CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 5.6, SECOND TEST INR = 3.4, THIRD TEST INR = 4.5.

    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 *