BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNEX/ALERE

    MDR report key: 2558044 · Received April 18, 2012

    Report

    Report Number
    MW5025244
    Event Type
    Other
    Date Received
    April 18, 2012
    Date of Event
    March 12, 2012
    Report Date
    April 18, 2012
    Manufacturer
    ALERE NORTH AMERICA, INC.
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEVERAL PTS HAVE NEEDED TO GET REDRAW FOR DS2 ERRORS, SINCE THEIR SAMPLES ARE TOO OLD TO SEND OUT TO A REFERENCE LAB. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNEX/ALERE DS2 KHO ALERE NORTH AMERICA, INC. DS2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other