BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 824161 · Received February 2, 2007

    Report

    Report Number
    2954730-2007-00048
    Event Type
    Malfunction
    Date Received
    February 2, 2007
    Date of Event
    January 18, 2007
    Report Date
    January 26, 2007
    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 01/17/06, INRATIO: 4.6, LAB: 11, MEAN: 7.8, CONFIDENCE LIMITS: CANNOT BE DETERMINED. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE CONFIDENCE LIMITS CANNOT BE DETERMINED. THE MEAN WAS > 5.0 AND THE DIFFERENCE BETWEEN INR'S IS > 2.2. THE READINGS CONSIDERED INACCURATE. PRODUCTS WILL BE TESTED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060415: FIRST TEST INR = 2.1, SECOND TEST INR = 2.0, THIRD TEST INR= 1.8, MEAN = 1.96; SD = 0.15; %CV = 7.7%. THE %CV IS LESS THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 01/17/06, INRATIO: 4.6, LAB: 11. PER TEXT "PT DIDN'T HAVE VISIBLE SYMPTOMS OF BLEEDING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060415

    Patients

    Seq Age Sex Outcome Treatment
    1 *