BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1033987 · Received April 24, 2008

    Report

    Report Number
    MW5006405
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    HEMOSENSE
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INTRATIO BY HEMOSENSE. LOT 070612A, EXPIRES 11/2008. STRIP CODE 720QX INR DONE ON A REGULAR PATIENT WHO NEVER VARIES AND IN WHOM NO CHANGES HAD OCCURRED. INR ON THIS BOX 4.1 AND 4.3, CONTROLS OK. PATIENT IS NEVER THIS HIGH AND PT AND NURSE DID NOT BELIEVE RESULT. NEW BOX, SAME LOT NUMBER BUT STRIP CODE DIFFERENT, RESULT 3.1, THE USUAL RESULT. DIAGNOSIS OR REASON FOR USE: BLOOD CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO NONE JPA HEMOSENSE 070615A

    Patients

    Seq Age Sex Outcome Treatment
    1