BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2043553 · Received March 25, 2011

    Report

    Report Number
    2027969-2011-00619
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO2 METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, PT: 1, INRATIO: 3.5, LAB: 2.4. DATE: (B)(6) 2011, PT: 2, INRATIO: 2.3, LAB: 1.99. PT #1 WAS ON LOVENOX. LESS THAN A HOUR BETWEEN INRATIO TEST AND LAB DRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 239277

    Patients

    Seq Age Sex Outcome Treatment
    1