BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1887239 · Received October 26, 2010

    Report

    Report Number
    2027969-2010-01808
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 1.3 (9:40AM), LAB: NG. DATE: (B)(6) /2010, NG, 6.9 (2AM). ON (B)(6) 2010: PT WAS SENT TO THE ER DUE TO SHORTNESS OF BREATH. ON (B)(6) 2010: PT HAD INTERNAL BLEEDING IN LUNGS AND WAS TREATED WITH VITAMIN K. PT'S THERAPEUTIC RANGE: 2.5-3.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 235739

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| L| R