BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2915451 · Received January 10, 2013

    Report

    Report Number
    2027969-2013-00021
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 10, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGING DISCREPANT LOW RESULTS ON ONE PT, ONE LOT, ONE METER. INRATIO 4.5, LAB 5.13, TESTS PERFORMED SIMULTANEOUSLY. PT MILKING FINGER. PT'S THERAPEUTIC RANGE 2.5 - 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16007 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 273310

    Patients

    Seq Age Sex Outcome Treatment
    1