BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3312609 · Received February 22, 2008

    Report

    Report Number
    2954730-2008-00085
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 28, 2008
    Manufacturer
    HEMOSENSE SJ
    Product Code
    GJS
    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. PER INTERNAL PROCEDURE, TR 0150, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS NOT REQUIRED AT THIS TIME. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070454: FIRST TEST INR = 2.7, SECOND TEST INR = 2.1, THIRD TEST INR = 3.7, FOURTH TEST INR = 3.8, MEAN = 3.075; SD = 0.82; %CV = 27%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED WHEN RETURNED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. CALLER ALLEGED INPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: INRATIO PRECISION DATA PROVIDED BY END-USER LOT 70454: FIRST TEST INR = 2.7. SECOND TEST INR = 2.1. THIRD TEST INR = 3.7. FOURTH TEST INR = 3.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS HEMOSENSE SJ 070454

    Patients

    Seq Age Sex Outcome Treatment
    1