BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2221675 · Received August 15, 2011

    Report

    Report Number
    2027969-2011-01818
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 8, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011, INRATIO: 2.5, LAB: 1.7; (B)(6) 2011, 2.3, 1.8; (B)(6) 2011, 3.0, 2.0; (B)(6) 2011, 2.3, 1.6. PATIENT'S TARGET THERAPEUTIC RANGE IS 2.0-3.0. LAB DONE 30 MINUTES AFTER METER RESULT ON (B)(6) 2011. ROUGHLY AN HOUR BETWEEN OTHER METER AND LAB COMPARISONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 254609

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR