BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 831842 · Received October 20, 2006

    Report

    Report Number
    2954730-2006-00541
    Event Type
    Malfunction
    Date Received
    October 20, 2006
    Date of Event
    October 12, 2006
    Report Date
    October 13, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060019: FIRST TEST INR = 2.8, SECOND TEST INR = 0.9, THIRD TEST INR = 1.1, FOURTH TEST INR=1.7. MEAN = 1.625; SD = 1.04; %CV = 64%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED. SEE SCANNED TABLE. BASED ON THE ABOVE TEST RESULTS, PER PR 0103, RETAINED STRIPS LOT 060019 MEETS THE CRITERIA FOR STRIP PRECISION.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 2.8, SECOND TEST INR = 0.9, THIRD TEST INR = 1.1, FOURTH TEST INR = 1.7. CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: SEE SCANNED TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060019

    Patients

    Seq Age Sex Outcome Treatment
    1