BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1001208 · Received February 22, 2008

    Report

    Report Number
    2954730-2008-00087
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 25, 2008
    Report Date
    February 22, 2008
    Manufacturer
    HEMOSENSE SJ
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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: 2008, INRATIO: 1.7, LAB: 2.4, MEAN: 2.1, CONFIDENCE LIMITS: 1.4 - 3.1. DATE: 2008, INRATIO: 1.9, LAB: 2.4, MEAN: 2.2, CONFIDENCE LIMITS: 1.4 - 3.1. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYS INR WERE CALCULATED. FOR BOTH DATA SETS, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS. THE RESULTS ARE CONSIDERED NOT DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: 2008, INRATIO: 1.7, LAB: 2.4; DATE: 2008, INRATIO: 1.9, LAB: 2.4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE SJ KIT, PROFESSIONAL USER, ENGLISH 070472

    Patients

    Seq Age Sex Outcome Treatment
    1