BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2934458 · Received January 11, 2013

    Report

    Report Number
    2027969-2013-00024
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 11, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH THE INRATIO METER COMPARED TO THE LAB FOR ONE PT. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO: 3.9, LAB: 1.5. TESTS WERE PERFORMED WITHIN TEN MINUTES OF EACH OTHER. PT'S THERAPEUTIC RANGE IS UNKNOWN. CALLER WAS UNABLE TO PROVIDE TECHNIQUE DETAILS AND LIMITED PT SPECIFIC INFORMATION BUT STATED THAT FACILITY HAS BEEN USING THE INRATIO METER FOR YEARS AND ALL OPERATORS ARE EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19289 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 291554

    Patients

    Seq Age Sex Outcome Treatment
    1 XERALTO| COUMADIN| PT RECENTLY STARTED PAIN MEDICATION