BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1893870 · Received November 1, 2010

    Report

    Report Number
    2027969-2010-01841
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PATIENT SELF TESTER REPORTS DISCREPANT RESULTS WITH METER COMPARED TO LAB. DATE: UNK, INRATIO: 1.6, LAB: 2.3, ("2 WEEKS AGO"). DATE: UNK, INRATIO: 1.2, LAB: 2.0, (LAB DONE 90 MINUTES LATER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHOMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 225324

    Patients

    Seq Age Sex Outcome Treatment
    1