BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2913046 · Received January 8, 2013

    Report

    Report Number
    2027969-2013-00015
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 8, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO: 0.9, LAB: 2.2. CALLER DID NOT PERFORM TEST; UNABLE TO PROVIDE TECHNIQUE INFO BUT STATES THAT ALL OPERATORS ARE EXPERIENCED WITH THE INRATIO METER. NURSE TESTED HERSELF ON THE INRATIO METER AND OBTAINED A RESULT WITHIN NORMAL RANGE. CALLER UNSURE BUT STATES THAT OPERATORS MAY BE LEAVING THE STRIPS IN THE CAR FOR AN EXTENDED AMOUNT OF TIME. THERAPEUTIC RANGE: 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10226 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 296410

    Patients

    Seq Age Sex Outcome Treatment
    1 PT IS ALSO TAKING MEDICATION FOR BLOOD PRESSURE,| COUAMDIN: 2MG / DAY| THYROID CONDITION AND PAIN MEDICATION.