BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1934000 · Received December 1, 2010

    Report

    Report Number
    2027969-2010-02096
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 9, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE REFERENCE METER. RESULTS AS FOLLOWS:" DATE: (B)(6) 2010; INRATIO: 3.1, 3.3, 3.6; DOCTOR'S METER: 3.9. PER PATIENT; TESTED USING DR'S INRATIO METER AND OBSERVED INR = 3.9. RETURNED HOME AND TESTED WITHIN 1/2 HOUR USING OWN INRATIO METER WITH INR = 3.1, 3.3, 3.6. DIFFERENT FINGERS USED. NO ISSUES WITH OBTAINING SUFFICIENT SAMPLE. THERAPEUTIC RANGE = 2.5-3.5. COUMADIN DOSE DECREASED SLIGHTLY BASED ON DR'S RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 239276

    Patients

    Seq Age Sex Outcome Treatment
    1