BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1983725 · Received February 4, 2011

    Report

    Report Number
    2027969-2011-00256
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    February 4, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WHILE PERFORMING A CORRELATION STUDY. THE FOLLOWING LOT NUMBERS WERE ALSO USED: 234588, 234880, 228758, 232167, 232171 AND 228759.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 222168

    Patients

    Seq Age Sex Outcome Treatment
    1