BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 2197759 · Received July 29, 2011

    Report

    Report Number
    2027969-2011-01681
    Event Type
    Other
    Date Received
    July 29, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 29, 2011
    Manufacturer
    ALRE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB. CUSTOMER DID CORRELATION STUDY. STATED THAT THE THERAPEUTIC RANGE FOR MOST PTS IS 2.0-3.0 AND THAT THE TIME BETWEEN METER AND LAB DRAWS WAS 5 MINUTES. CUSTOMER STATED THAT LOVENOX WAS GIVEN TO PTS WITH INR RESULTS LOWER THAN 1.5.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other