BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2060686 · Received April 8, 2011

    Report

    Report Number
    2027969-2011-00740
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO2 METER. PHYSICIAN REQUESTED FOR PT SELF TESTER TO HOLD OFF ON COUMADIN FOR 2 DAYS ON (B)(6) 2011. PT RESUMED 5MG DOSE ON (B)(6) 2011. COUMADIN DOSE REGIMEN: 10MG ON SUNDAY, MONDAY, WEDNESDAY AND FRIDAY; 5MG ON TUESDAY, THURSDAY AND SATURDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 246050

    Patients

    Seq Age Sex Outcome Treatment
    1