BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 698259 · Received October 5, 2005

    Report

    Report Number
    2954730-2005-00074
    Event Type
    Malfunction
    Date Received
    October 5, 2005
    Date of Event
    September 7, 2005
    Report Date
    October 4, 2005
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PER PR 0103, STRIP ACCURACY IS DETERMINED BY COMPARING THE INR VALUE OBTAINED FROM THE MLA (REFERENCE SYSTEM) TO THE INRATIO INR VALUES FROM PATIENT TESTING. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND THE MLA INRS ARE AS FOLLOWS: IF THE MLA INR IS <2.0, THEN THE ALLOWED DIFFERENCE IS +/- 0.5, IF THE MLA INR IS 2.0 -4.5, THEN THE ALLOWED DIFFERENCE IS +/- 1.0. STRIP ACCURACY RESULTS: SEE SCANNED TABLE. LOT 050255 MEETS THE CRITERIA FOR STRIP ACCURACY. NO FURTHER TESTING IS REQUIRED.

    Description of Event or Problem · 1

    THE SUSPECT METER EXHIBITED VARIATION IN TEST RESULTS WHEN COMPARED WITH THE LAB. THE FOLLOWING RESULTS WERE REPORTED. INRATIO 0.8, LAB 2.4, IN RAIO 0.9, 2.7 (REPEAT) LAB 2.2, INRATIO 2.9. A REPLACEMENT METER WAS SENT TO THE CUSTOMER. THE SUSPECT METER SHALL BE RETURNED FOR EVALUATION PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TEST TIME JPA HEMOSENSE, INC. * 050255

    Patients

    Seq Age Sex Outcome Treatment
    1 *