BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA

    MDR report key: 1028078 · Received April 11, 2008

    Report

    Report Number
    2954730-2008-00178
    Event Type
    Malfunction
    Date Received
    April 11, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 8, 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: 070614. FIRST TEST INR = 5.9, SECOND TEST INR = 4.9. MEAN = 5.40; SD = 0.71; %CV = 13.1. THE %CV IS LESS THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND FURTHER TESTING IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 5.9. SECOND TEST INR 4.9.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1