BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2833413 · Received October 26, 2012

    Report

    Report Number
    2027969-2012-01568
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    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 ALLEGES PRECISION ISSUES. DISCREPANT LOW RESULT ON INRATIO METER, ONE LOT, ONE METER, ONE PT. PT SELF TESTER TESTED TWICE AND RECEIVED TWO DIFFERENT READINGS ON INRATIO METER. INRATIO = 4.2, 2 HOURS LATER 1.9. LAB = 4.7. TIME BETWEEN INITIAL INRATIO TEST AND LAB = 1 HOUR. TIME BETWEEN LAB AND SECOND INRATIO TEST = 1 HOUR. PT'S THERAPEUTIC RANGE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 279124

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN