BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1763296 · Received June 30, 2010

    Report

    Report Number
    2027969-2010-00880
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 30, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. RESULTS AS FOLLOWS:" DATE: (B)(6) 2010, INRATIO: 1.2, LAB: 2.8. VENOUS BLOOD DRAW DONE WITHIN ONE HOUR OF CAPILLARY DRAW. NO HEPARIN, LOVENOX. NO CANCER, ANEMIA, APS, LUPUS. NO RECENT ABX. NO CHANGES IN MEDICATIONS. SLIGHT CHANGE IN EATING HABITS. NO AMIODARONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 230370

    Patients

    Seq Age Sex Outcome Treatment
    1