BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 829707 · Received October 27, 2006

    Report

    Report Number
    2954730-2006-00564
    Event Type
    Malfunction
    Date Received
    October 27, 2006
    Date of Event
    October 25, 2006
    Report Date
    October 26, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: FIRST TEST INR = 1.8(060355); SECOND TEST INR= 1.0(060177); MEAN = 1.4; SD = 0.56; %CV =40%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PER TEST "THE EXPIRED DEMO STRIPS HAVE ALWAYS GIVEN STEVE'S RESULT BETWEEN 1.0 TO 1.1" CALLER COMPARED WITH EXPIRED STRIPS. PRODUCTS MISUSED. NO FURTHER INVESTIGATION REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR =1.8 (060355); SECOND TEST INR = 1.0 (060177).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060355

    Patients

    Seq Age Sex Outcome Treatment
    1 *