BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2146256 · Received June 24, 2011

    Report

    Report Number
    2027969-2011-01401
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT #: 253026. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB. INRATIO RESULTS ON (B)(6) 2011 DONE AT 8:33 AM, LAB RESULT ON SAME DAY DONE AT 10:00 AM. ON (B)(6) 2011, THE LAB DRAW WAS PERFORMED IMMEDIATELY AFTER THE METER RESULT. ON (B)(6) 2011, THE LAB DRAW WAS PERFORMED LESS THAN 30 MINUTES AFTER THE METER RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 251112

    Patients

    Seq Age Sex Outcome Treatment
    1