BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2022516 · Received February 15, 2011

    Report

    Report Number
    2027969-2011-00325
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 2.7. DATE: (B)(6) 2011, INRATIO: 2.7, RE-TEST: 1.2. TEST AND RE-TEST WERE DONE WITHIN 45 MINUTES. RE-TEST WAS PERFORMED WITH BLOOD THAT RAN DOWN THE PT'S FINGER AND APPLIED WITH A MICRO SAFE TUBE. PT REPORTS HAVING A HARD TIME GETTING THE GREEN LIGHT TO COME ON WHEN APPLYING THE BLOOD SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243103

    Patients

    Seq Age Sex Outcome Treatment
    1