BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMX TACROLIMUS II REAGENT PACK

    MDR report key: 642158 · Received October 20, 2005

    Report

    Report Number
    1415939-2005-00026
    Event Type
    Injury
    Date Received
    October 20, 2005
    Report Date
    October 20, 2005
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MLM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT STATES PHYSICIANS ARE QUESTIONING THE VARIABILTIY IN PT RESULTS GENERATED ON THE IMX TACROLIMUS II ASSAY. A CONFERENCE CALLED WAS HELD IN 2005 REGARDING THIS ISSUE AND REPRESENTATIVES FROM THE ACCOUNT AND ABBOTT LABORATORIES WERE IN ATTENDANCE. THE ACCOUNT STATED THAT THERE HAS BEEN AN INCREASE IN KIDNEY REJECTION RATE IN PTS. NO SPECIFIC PT INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMX TACROLIMUS II REAGENT PACK MEIA FOR THE MEASUREMENT OF TACROLIMUS MLM ABBOTT LABORATORIES NA 30496M100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other