BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2132412 · Received June 13, 2011

    Report

    Report Number
    2027969-2011-01318
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER. PATIENT SELF TESTER TESTS EVERY SINGLE DAY. PATIENT DID NOT TAKE HER COUMADIN DOSE ON (B)(6) 2011 BASED ON HER INR RESULTS. MEDICATION WAS RESUMED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 248203

    Patients

    Seq Age Sex Outcome Treatment
    1