BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1013962 · Received March 14, 2008

    Report

    Report Number
    2954730-2008-00116
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 11, 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: 070415. FIRST TEST INR = 1.0, SECOND TEST INR= 2.8, THIRD TEST INR= 2.9; MEAN = 2.2; SD = 1.1; %CV = 47.9. FIRST TEST INR = 0.9; SECOND TEST INR= 2.8, MEAN= 1.9; SD = 1.3; %CV = 72.6. THE % CV IS GREATER THAN 20 % FOR BOTH DATA SETS. 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 = 1.0; SECOND TEST INR= 2.8; THIRD TEST INR= 2.9. FIRST TEST INR= 0.9; SECOND TEST INR= 2.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE SJ BOXED STRIPS, 48 STRIPS, MULTIPA 070415

    Patients

    Seq Age Sex Outcome Treatment
    1