BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1833294 · Received September 9, 2010

    Report

    Report Number
    2027969-2010-01401
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 19, 2010
    Report Date
    September 9, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: PT 1, INRATIO: 3.3, LAB: 1.8. PT 2, INRATIO: 2.2, LAB: 1.7. RESULTS WERE TAKEN WITHIN 15 MINS OF EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 234586

    Patients

    Seq Age Sex Outcome Treatment
    1