BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 900518 · Received August 20, 2007

    Report

    Report Number
    2954730-2007-00373
    Event Type
    Malfunction
    Date Received
    August 20, 2007
    Date of Event
    July 30, 2007
    Report Date
    August 15, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070281: DATE 2007, FIRST TEST INR = 4.8, SECOND TEST INR = 2.9, THIRD TEST INR = 1.1. MEAN = 2.93; SD = 1.85; %CV = 63.07%. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070202: DATE 2007, FIRST TEST INR = 5.5, SECOND TEST INR = 3.2, THIRD TEST INR = 5.6. MEAN = 4.76; SD = 1.36; %CV = 28.48%. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: REPLACEMENT METER DATE 2007, FIRST TEST INR = 2.3, SECOND TEST INR = 2.0. MEAN = 2.15; SD = 0.21; %CV = 9.86%. THE %CV IS GREATER THAN 20% FOR DATA SETS SEVEN DAYS IN 2007. REPLACEMENT METER SEEMS TO BE WORKING FINE IN 2007, %CV IS LESS THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILS THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED NOT PRECISE AND FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 4.8, SECOND TEST INR = 2.9, THIRD TEST INR = 1.1. FIRST TEST INR = 5.5, SECOND TEST INR = 3.2, THIRD TEST INR = 5.6. FIRST TEST INR = 2.3, SECOND TEST INR = 2.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070281

    Patients

    Seq Age Sex Outcome Treatment
    1 YR