BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 963155 · Received December 10, 2007

    Report

    Report Number
    2954730-2007-00710
    Event Type
    Malfunction
    Date Received
    December 10, 2007
    Date of Event
    November 20, 2007
    Report Date
    December 10, 2007
    Manufacturer
    HEMOSENSE SJ
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070381: UNIT 2 FIRST- TEST INR = 5.0; SECOND TEST INR = 2.5; THIRD TEST INR = 1.0; MEAN = 2.83; SD = 2.0; %CV = 71%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT THE TIME COMPLAINT WAS FILED: DATE: 2007; INRATIO: 5.0; LAB: 1.2; MEAN: 3.1; CONFIDENCE LIMITS: 1.9-4.6; INRATIO: 2.5; LAB: 1.2; MEAN: 1.85; CONFIDENCE LIMITS: 1.3-2.7; INRATIO: 1.0; LAB: 1.2; MEAN: 1.1; CONFIDENCE LIMITS: 1.0 - 1.5. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST AND SECOND SETS OF DATA, THE INRATIO VALUES ARE OUTSIDE THE CONFIDENCE LIMITS FOR INR TESTING. PRODUCTS WILL BE TESTED WHEN RETURNED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2007; INRATIO: 5.0; LAB: 1.2; INRATIO: 2.5; LAB: 1.2; INRATIO: 1.0; LAB: 1.2. CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: 2007, UNIT 2; FIRST TEST INR = 5.0; SECOND TEST INR = 2.5; THIRD TEST INR = 1.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE SJ 070381

    Patients

    Seq Age Sex Outcome Treatment
    1 YR