BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1735124 · Received June 3, 2010

    Report

    Report Number
    2027969-2010-00691
    Event Type
    Malfunction
    Date Received
    June 3, 2010
    Date of Event
    May 12, 2010
    Report Date
    June 2, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO AND INRATIO2 METERS WERE BEING TESTED. THE 510 (K) LISTED IS FOR THE INRATIO TEST. THE 510(K) FOR THE INRATIO2 TEST IS: K072727. NO METER SERIAL NUMBERS WERE PROVIDED. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS ON INRATIO METER COMPARED WITH INRATIO2 METER. RESULTS AS FOLLOWS:" DATE: (B)(6)2010, INRATIO: 1.6, INRATIO2, 1.2. DATE: (B)(6)2010, INRATIO: 1.3 INRATIO2: 2.1. FIRST COMPARISON WAS DONE USING DIFFERENT FINGERS FOR SAMPLE. SECOND COMPARISON WAS DONE USING THE SAME FINGERSTICK FOR BOTH TESTS. SAME OPERATOR RAN BOTH TESTS. NO PATIENT HISTORY WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 229062

    Patients

    Seq Age Sex Outcome Treatment
    1