BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2052497 · Received March 15, 2011

    Report

    Report Number
    2027969-2011-00504
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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, PATIENT: 1, INRATIO: 2.7, COAGUCHECK: 3.7. DATE: (B)(6) 2011, PATIENT: 2, INRATIO: 1.9, COAGUCHECK: 3.4. THE CUSTOMER IS TESTING FIRST ON THE COAGUCHECK, AND THEN USING THE SAME FINGER STICK TO TEST ON THE INRATIO2 METER. CUSTOMER ALSO REPORTS THAT THE PATIENTS MAY BE ON HEPARIN. NO OTHER PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 243700

    Patients

    Seq Age Sex Outcome Treatment
    1