BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2073087 · Received April 13, 2011

    Report

    Report Number
    2027969-2011-00884
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    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

    CALLER ALLEGED DISCREPANT PRECISION RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011; INRATIO: 3.8; RE-TEST: 2.3; RE-TEST: 2.4. DIFFERENT FINGER STICKS AND DIFFERENT FINGERS WERE USED FOR EACH SAMPLE. CALLER REPORTS THAT THEY DO NOT CHANGE THE TEST STRIP CODE AND THAT THEY "MILK THE FINGER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1