BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1013972 · Received March 14, 2008

    Report

    Report Number
    2954730-2008-00120
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 12, 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 THE TIME COMPLAINT WAS FILED. DATE: 2008, INRATIO: 3.0, LAB: 4.5, MEAN: 4.0, CONFIDENCE LIMITS: 2.3 - 5.7; DATE: A WEEK LATER, INRATIO: 2.2, LAB: 3.6, MEAN: 2.9, CONFIDENCE LIMITS: 1.8 - 4.2; DATE: NINE DAYS LATER, INRATIO: 2.6, LAB: 3.8, MEAN: 3.2, CONFIDENCE LIMITS: 1.9 - 4.6; DATE: SAME DAY: INRATIO: 2.4, LAB: 3.8, MEAN: 3.1, CONFIDENCE LIMITS: 1.9 - 4.6, DATE: SIX DAYS LATER, INRATIO: 3.0, LAB: 4.4, MEAN: 3.7, CONFIDENCE LIMITS: 2.2 - 5.3, DATE: SAME DAY, INRATIO: 2.6, LAB: 4.4, MEAN: 3.5, CONFIDENCE LIMITS: 2.0 - 5.0. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR ALL 6 DATA SETS, 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.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: 2008, INRATIO: 3.0, LAB: 4.5; DATE: THE FOLLOWING MONTH, INRATIO: 2.2, LAB: 3.6; DATE: NINE DAYS LATER, INRATIO: 2.6, LAB: 3.8; DATE: THE SAME DAY, INRATIO: 2.4, LAB: 3.8; DATE: SIX DAYS LATER, INRATIO: 3.0, LAB: 4.4; SAME DAY, INRATIO: 2.6, LAB: 4.4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE SJ KIT, SELF-TEST, ENGLISH 070614

    Patients

    Seq Age Sex Outcome Treatment
    1