BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2082613 · Received April 27, 2011

    Report

    Report Number
    2027969-2011-00941
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    February 16, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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 INR: 1.9 AND 1.8, LAB INR: 2.9. BACK TO BACK TESTS. PT WENT TO HEALTH CARE PROVIDER AN HOUR LATER AND HAD A VENOUS DRAW AND RECEIVED INR LEVEL OF 2.9 WHICH IS NORMAL FOR THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 237411

    Patients

    Seq Age Sex Outcome Treatment
    1 NI