BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2090669 · Received April 19, 2011

    Report

    Report Number
    2027969-2011-00862
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    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 INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, 1ST INRATIO: 15 SOMETHING, 2ND INRATIO: 1.0 SOMETHING. CALLER WAS UNABLE TO PROVIDE EXACT RESULTS. PT'S THERAPEUTIC RANGE IS: (2-3). PATIENT IS ON COUMADIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 243700

    Patients

    Seq Age Sex Outcome Treatment
    1 NI