BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2111837 · Received May 26, 2011

    Report

    Report Number
    2027969-2011-01173
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISPLAY OF "ERROR 114" THREE TIMES WITH ONE PATIENT BRIDGING FROM PRADAXA. FACILITY DOES NOT NORMALLY TEST PATIENTS ON PRADAXA, BUT THIS PATIENT CAME IN TO SEE HIS PHYSICIAN AND WAS TESTED BECAUSE HE WAS EXPERIENCING ORAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 247450

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other