BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1841066 · Received September 15, 2010

    Report

    Report Number
    2027969-2010-01477
    Event Type
    Injury
    Date Received
    September 15, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 1.1, PT: 17.3. DATE: (B)(6) 2010, INRATIO: 66, PT: >120.0. PATIENT WENT TO THE HOSPITAL ON (B)(6) 2010, FOR A NOSE BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 234589

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization