BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2932366 · Received January 22, 2013

    Report

    Report Number
    2027969-2013-00073
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 21, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH THE INRATIO2 METER. SUMMARY OF REPORTED RESULTS: DATE: (B)(6) /2013, INRATIO RESULTS: (1.6, 0.9, 1.4). TIME BETWEEN FIRST AND SECOND RESULT IS EIGHT MINUTES; TIME BETWEEN SECOND AND THIRD RESULT IS FEW MINUTES (UNKNOWN EXACT TIME). PT'S THERAPEUTIC RANGE IS 2.5-3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31637 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 295675

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| CURRENT MEDICATIONS.| PT SAID NO NEW MEDICATIONS AND NO CHANGES TO HER