BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1962542 · Received January 7, 2011

    Report

    Report Number
    2027969-2011-00047
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    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

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: QC2H ERROR, INRATIO: QC1H ERROR, LAB: 5.3. CALLER REPORTED GETTING QC2H ERRORS THREE TIMES AND QC1H ERROR ONE TIME USING THE INRATIO METER. CALLER ALSO REPORTS BLOOD IN HER URINE. PT IS ON HER MENSTRUAL CYCLE, BUT REPORTS THAT BLOOD IS MORE THAN NORMAL. PT WAS PRESCRIBED ANTIBIOTICS FOR A URINARY TRACT INFECTION BUT HAD NOT YET TAKEN THEM. PT ALSO ATE A LOT OF GREEN VEGETABLES TO LOWER HER INR BASED UPON THE LAB RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 237411

    Patients

    Seq Age Sex Outcome Treatment
    1 Other