BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2904018 · Received January 3, 2013

    Report

    Report Number
    2027969-2013-00003
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    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 INRATIO RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO INR: 1.8 AND 2.2, POC INR: 3.3 AND 3.4, LABORATORY INR: 3.8. THE TIME BETWEEN TESTING WAS 15 MINUTES BETWEEN METERS AND WITHIN 30 MINUTES BETWEEN METERS AND LABORATORY TESTING. PT STATED THAT TWO FINGERS WERE PUNCTURED AND EACH FINGER WAS PUNCTURED A SECOND TIME FOR THE REPEAT TEST. UNSURE WHICH METER WAS TESTED ON FIRST. THERAPEUTIC RANGE 2.5 - 3.5 FOR PT. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3601 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 294386

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN