BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2130357 · Received May 9, 2011

    Report

    Report Number
    2027969-2011-01024
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO2 METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 4.6, RE-TEST: 2.5, LAB: 1.8. INRATIO METER TESTS WERE 5 MINUTES APART USING FRESH FINGER STICKS. LAB DRAW WAS PERFORMED WITHIN ABOUT 20-30 MINUTES OF SECOND INRATIO2 RESULT. CUSTOMER HAD THE WRONG STRIP CODE IN THE INRATIO METER, AND WAS NOT SURE HOW TO CHANGE IT. REPLACING STRIPS AND METER FOR CUSTOMER.

    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