BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2123571 · Received June 9, 2011

    Report

    Report Number
    2027969-2011-01289
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: 1.1, LAB: 2.11. CALLER IS THE OFFICE MANAGER, SO SHE HAD VERY LITTLE DETAILS. LAB DRAW DONE SAME DAY AS INRATIO TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 237431

    Patients

    Seq Age Sex Outcome Treatment
    1