BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2070740 · Received April 14, 2011

    Report

    Report Number
    2027969-2011-00827
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: PATIENT: 1, DATE: (B)(6) 2011, INRATIO2: 6.2, LAB: 3.5. PATIENT: 2, (B)(6) 2011, 2.6, 2.1. PATIENT 3: (B)(6) 2011, 2.7, 1.4. PATIENT 4: (B)(6) 2011, 7.5, 5.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 247456

    Patients

    Seq Age Sex Outcome Treatment
    1