BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2854280 · Received November 28, 2012

    Report

    Report Number
    2027969-2012-01641
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 28, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH THE INRATIO METER COMPARED TO THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO INR: 1.1, LAB INR: 1.8. THE TIME BETWEEN TESTING WAS 10 MINUTES. THERAPEUTIC RANGE WAS NOT PROVIDED FOR PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 279821

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN