BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1070793 · Received July 3, 2008

    Report

    Report Number
    2954730-2008-00449
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 4, 2008
    Report Date
    July 2, 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 THE TIME COMPLAINT WAS FILED: DATE: 2008; INRATIO: 5.6, 6.3; LAB: 4.3, 4.3; MEAN: 4.95, 5.3; CONFIDENCE LIMITS: 2.8-7.2, CANNOT BE DETERMINED. PER INTERNAL PROCEDURE, TR 0150, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE SECOND SET OF DATA, THE CONFIDENCE LIMITS CANNOT BE DETERMINED. PRODUCT WILL BE TESTED. INRATIO PRECISION DATA PROVIDED BY END-USER, LOT 070565: FIRST TEST INR = 5.6, SECOND TEST: INR= 6.3, MEAN = 5.95; SD=0.49; % CV= 8.3%. THE % CV IS LESS THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, TR0150, 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: 2008; INRATIO: 5.6, 6.3; LAB: 4.3, 4.3. CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: FIRST TEST INR = 5.6; SECOND TEST INR = 6.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100004 070565

    Patients

    Seq Age Sex Outcome Treatment
    1 NI