BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2000521 · Received February 1, 2011

    Report

    Report Number
    2027969-2011-00221
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 31, 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 ALLEGED DISCREPANT RESULTS WITH METER COMPARED TO LAB: PT 1; DATE: (B)(6) 2011, INRATIO: 1.1, LAB: 3.8; PT 2; (B)(6) 2011, INRATIO: 1.8, 2ND INRATIO: 3.2. PT 1 WENT TO LAB WITHIN 20 MINUTES OF METER RESULT. PT 2 SECOND RESULT WAS FROM A DIFFERENT METER AND WAS DONE MINUTES AFTER THE FIRST RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 235740

    Patients

    Seq Age Sex Outcome Treatment
    1