BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1095445 · Received July 31, 2008

    Report

    Report Number
    2954730-2008-00484
    Event Type
    Malfunction
    Date Received
    July 31, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 29, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    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: SEE SCANNED TABLE. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST SET OF DATA, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. FOR THE SECOND SET OF DATA, THE CONFIDENCE LIMITS CANNOT BE DETERMINED. FOR THE THIRD SET OF DATA, THE INRATIO AND LAB VALUES WERE > 5.0. THE COMPARISON WAS NOT CONSIDERED INACCURATE. PRODUCTS WILL BE TESTED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070615: FIRST TEST INR = 3.2, SECOND TEST INR = 4/9, THIRD TEST INR= 5.6, MEAN = 4.6, SD = 1.2, %CV = 27%. 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: 2008, IN RATIO: 3.2, 4.9, 5.6, LAB: 5.56, 5.56, 5.56.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100004 070615

    Patients

    Seq Age Sex Outcome Treatment
    1 NI