BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1763323 · Received June 30, 2010

    Report

    Report Number
    2027969-2010-00873
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    May 24, 2010
    Report Date
    June 30, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. NO HEPARIN, LOVENOX. NO CANCER, ANEMIC. (B)(6). NO THYROID CONDITION. NO APS, LUPUS. HYPERTENSIVE. COUMADIN FOR AT LEAST 1 YEAR. NO ABX. NO RECENT LIFE CHANGES. TAKING ANTIARRHYTHMIC MEDICATION FOR CHRONIC A-FIB (ADJUSTING DOSE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 224379

    Patients

    Seq Age Sex Outcome Treatment
    1