BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1024198 · Received March 27, 2008

    Report

    Report Number
    2954730-2008-00146
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 25, 2008
    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 070299: PT#1: FIRST TEST INR =5.3(METER 1), SECOND TEST INR = 4.3(METER 2), MEAN = 4.8; SD = 0.7; %CV = 15%. THE %CV IS LESS THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070299: PT#2: FIRST TEST INR = 2.2(METER 1), SECOND TEST INR = 1.1(METER 2), MEAN = 1.65; SD = 0.77; %CV = 47%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED WHEN RETURNED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: PT#1: FIRST TEST INR = 5.3(METER 1), SECOND TEST INR = 4.3(METER 2); PT#2: FIRST TEST INR = 2.2(METER 1), SECOND TEST INR = 1.1(METER 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE SJ 070299

    Patients

    Seq Age Sex Outcome Treatment
    1