BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3050310 · Received March 7, 2013

    Report

    Report Number
    2027969-2013-00197
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH THE INRATIO2 METER. COMPLAINT SUMMARY: DATE: (B)(6) 2013, INRATIO RESULTS: (7.3, 6.2, 4.9). ALL RESULTS OBTAINED WITHIN 2 HOURS. PT'S THERAPEUTIC RANGE IS 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98458 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 299622

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN