BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1781389 · Received July 30, 2010

    Report

    Report Number
    2027969-2010-01096
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 30, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PT SELF TESTER REPORTED DISCREPANT RESULTS: (B)(6) 2010, INRATIO: 1.3; (B)(6) 2010, INRATIO: 1.6, LAB: 2.5. PT'S THERAPEUTIC RANGE IS 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 234130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AN ACE INHIBITOR| MAINTANENCE PROTOCOL OF BACTRIM (BECAUSE PATIENT| FLOMAX| 80MG PER DAY OF AN UNK DIURETIC| LASIX| METHOTREXATE| IS IMMUNOCOMPROMISED)| A STATIN (FOR ELEVATED CHOLESTEROL)| INSULIN