BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1825279 · Received August 30, 2010

    Report

    Report Number
    2027969-2010-01297
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 30, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PATIENT SELF TESTER REPORTS HIGHER THAN EXPECTED RESULTS WITH METER FOR APPROXIMATELY 3 WEEKS (4.4-4.6). PATIENT RECEIVED NEW STRIPS (#234130) AND CONTINUED TO RECEIVE RESULTS IN THE 4.4-4.6 RANGE. PATIENT LAB RESULT=2.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234130

    Patients

    Seq Age Sex Outcome Treatment
    1