BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2043573 · Received March 25, 2011

    Report

    Report Number
    2027969-2011-00621
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATES: (B)(6) 2011, INRATIO: 2.8, LAB: 1.5 (LAB TEST OBTAINED WITHIN THE HOUR), PATIENT THERAPEUTIC RANGE: 2.0-3.0. NO CHANGES IN DIET OR MEDICATIONS REPORTED. PATIENT IS MILKING FINGER AND POSSIBLY APPLYING SECOND DROP OF BLOOD AS THE PATIENT SEES NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 241836

    Patients

    Seq Age Sex Outcome Treatment
    1 NI