BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1972245 · Received January 21, 2011

    Report

    Report Number
    2027969-2011-00147
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 20, 2011
    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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    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; 1.8; LAB: 8.7. PT WAS SENT TO THE HOSPITAL BECAUSE HE HAD BLOOD IN HIS URINE. PT'S THERAPEUTIC RANGE: 2.0-3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 237433

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| O