BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2212912 · Received July 12, 2011

    Report

    Report Number
    2027969-2011-01527
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO: 0.7, 2.7, LAB: 2.2. THE 2.7 INRATIO RESULT WAS OBSERVED A FEW HOURS AFTER THE LAB TEST. THERAPEUTIC RANGE 2.0-3.0. CUSTOMER SAYS WHEN THE 0.7 WAS OBTAINED, THE PT HAD STUCK HERSELF WITH THE METER STILL ON THE STRIP CODE SCREEN AND THERE WAS SIGNIFICANT DELAY BEFORE THE BLOOD WAS APPLIED. TECH SERVICE REP ADVISED CUSTOMER TO WAIT UNTIL THE APPLY SAMPLE SCREEN/GREEN LIGHT BEFORE PERFORMING THE FINGERSTICK AND APPLYING THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 243104

    Patients

    Seq Age Sex Outcome Treatment
    1