BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 3023813 · Received March 25, 2013

    Report

    Report Number
    2027969-2013-00243
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ALERE SAN DIEGO
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANCY INRATIO RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, INRATIO: 5.1, LAB: 8.1. ONE HOUR BETWEEN INRATIO AND LAB TESTING. PT WAS ADMITTED TO THE HOSPITAL DUE TO FACIAL BLEEDING; INR WAS TAKEN AT THE LAB. THERAPEUTIC RANGE: 1.0 - 3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121675 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO 100139 296410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization FURESMIDE| WARFARIN| VITAMINS| LISINOPRIL| PLAVIX| METAPROL