BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 980501 · Received January 11, 2008

    Report

    Report Number
    2954730-2007-00736
    Event Type
    Malfunction
    Date Received
    January 11, 2008
    Date of Event
    December 18, 2007
    Report Date
    December 31, 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 070281: FIRST TEST INR = 3.8; SECOND TEST INR = 3.0; MEAN = 3.4; SD = 0.57; %CV = 16.6%. FIRST TEST INR= 3.7; SECOND TEST INR= 3.0; MEAN = 3.4; SD = 0.49; %CV = 14.8%. FIRST TEST INR = 4.2, SECOND TEST INR = 3.0; MEAN = 3.6; SD = 0.85; %CV = 23.6%. FIRST TEST INR = 3.4; SECOND TEST INR = 2.8; MEAN = 3.1; SD = 0.42; %CV = 13.7%. FIRST TEST INR = 3.4; SECOND TEST = 2.6; MEAN = 3.0; SD = 0.57; %CV = 18.9%; FIRST TEST INR = 3.1; SECOND TEST INR = 2.5; MEAN = 2.8; SD = 0.42; %CV = 15.2%. THE %CV IS GREATER THAN 20% FOR ALL THE DATA SETS EXCEPT FOR DATA SET 3. PER INTERNAL PROCEDURE, THE PRECISION FAILS THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED NOT PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLOWS: FIRST TEST INR = 3.8; SECOND TEST INR = 3.0. FIRST TEST INR = 3.7; SECOND TEST INR = 3.0. FIRST TEST INR = 4.2; SECOND TEST INR = 3.0. FIRST TEST INR = 3.4; SECOND 2.8. FIRST TEST INR = 3.4; SECOND TEST INR = 2.6. FIRST TEST INR = 3.1; SECOND TEST INR = 2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, SJ KIT, MULTI, ANGLO SAXON LATIN 070281

    Patients

    Seq Age Sex Outcome Treatment
    1