BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2915460 · Received January 10, 2013

    Report

    Report Number
    2027969-2013-00023
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 17, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH THE INRATIO METER COMPARED TO THE LAB. RESULTS AS FOLLOW: DATE (B)(6) 2012, LAB 3.1, INRATIO 1.6. FINGER-STICK WAS NOT PERFORMED; VENOUS SAMPLE WAS USED TO TEST ON THE INRATIO METER. PT'S THERAPEUTIC RANGE: 2.0 - 2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16090 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 285228

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN