BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3177583 · Received February 22, 2008

    Report

    Report Number
    2954730-2008-00086
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 22, 2008
    Manufacturer
    HEMOSENSE SJ
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT: 070384. FIRST TEST INR = 1.9; SECOND TEST INR = 2.0; THIRD TEST INR = 1.0; MEAN = 1.63; SD = 0.55; %CV = 33.7. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, TR 0150, 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

    CUSTOMER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 1.9; SECOND TEST INR = 2.0; THIRD TEST INR = 1.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS HEMOSENSE SJ BOXED STRIPS, 48 STRIPS, MULTIP 070384

    Patients

    Seq Age Sex Outcome Treatment
    1