BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2070741 · Received April 14, 2011

    Report

    Report Number
    2027969-2011-00821
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2.1, LAB: 1.8, DATE: (B)(6) 2011, 2, 1.9, 2.2. DATE: (B)(6) 2011, 3, 2.1, 2.3. DATE: (B)(6) 2011, 4, 1.2, 1.4. DATE: (B)(6) 2011, 5, 1.4, 2.0. DATE: (B)(6) 2011, 6, 1.0, 1.1. DATE: (B)(6) 2011, 7, 1.6, 2.4. PATIENTS WERE TESTED ON THE METER AND IN THE LAB WITHIN MINUTES OF ONE ANOTHER. NO PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 239279

    Patients

    Seq Age Sex Outcome Treatment
    1