BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1984465 · Received February 1, 2011

    Report

    Report Number
    2027969-2011-00228
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 10, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, PATIENT: 1, INRATIO: 5.2, LAB: 11. DATE: NG, PATIENT: 2, INRATIO: 5.X, PATIENT 1 HAD BLEEDING FROM THE MOUTH AND SEVERE ABDOMINAL PAIN. PATIENT 2 WAS REPORTED TO BE "ACTIVELY BLEEDING".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other